- PK modeling knowledge present insights into potential dosing conversions and methods for switching to UZEDY from a long-acting injectable (LAI) formulation of risperidone microspheres (R064766)
- Further UZEDY knowledge embody a brand new evaluation from the Section 3 RISE trial reinforcing its efficacy and security profile in adults with schizophrenia
- ADVANCE, a worldwide survey research, can even present real-world findings on LAI utilization from healthcare professionals, caregivers and sufferers
TEL AVIV, Israel & PARSIPPANY, N.J.–(BUSINESS WIRE)–Teva Prescription drugs, a U.S. affiliate of Teva Pharmaceutical Industries (NYSE:) Ltd. (NYSE and TASE: TEVA), at this time introduced the presentation of eight research from its LAI schizophrenia analysis program, together with knowledge evaluating UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use each one or two months for the therapy of schizophrenia in adults. The info have been introduced on the 2024 Congress of the Schizophrenia Worldwide Analysis Society (SIRS) happening from April 3-7, 2024 in Florence, Italy.
As a part of Teva’s dedication to advancing therapy innovation for schizophrenia sufferers, this analysis offers medical insights into how healthcare suppliers could change acceptable sufferers to UZEDY, a subcutaneous risperidone LAI choice with versatile dosing, mentioned Eric Hughes, MD, Ph.D, Govt Vice President of International R&D and Chief Medical Officer at Teva. Schizophrenia is a posh psychological well being situation the place the therapy wants and preferences of these dwelling with it could evolve over time. These knowledge collectively show the efficacy and security profile of UZEDY “ reinforcing its potential as a therapy choice which will assist decrease charges of relapse and hospitalization.
Introduced knowledge embody inhabitants pharmacokinetic (PopPK) modeling to research dosing conversion methods for switching sufferers to a once-monthly or as soon as each two-months subcutaneous dose of UZEDY from a biweekly intramuscular LAI formulation of risperidone microspheres (R064766). The evaluation goals to deal with the information hole as restricted medical knowledge presently exist on optimum methods for switching between the assorted accessible LAI therapy choices, which have differing pharmacokinetic (PK) properties.
Within the PopPK evaluation, affected person mannequin simulations confirmed that switching to UZEDY at 4-6 weeks after the final dose of R064766 offered comparable PK exposures by the second dose. Particularly, switching sufferers to UZEDY 5 weeks after the final dose of R064766 achieved PK exposures just like these achieved with R064766 at a gradual state. The optimum switching technique needs to be decided by clinicians on a person foundation, contemplating components corresponding to affected person desire, scheduling comfort, and potential tolerability points or threat of symptom breakthrough.
Further key knowledge being introduced on the SIRS Annual Assembly embody:
New knowledge from RISE (Risperidone Subcutaneous Prolonged-Launch Research), the Section 3 pivotal trial that supported the FDA approval of UZEDY. An evaluation estimated the quantity wanted to deal with (NNT) and the quantity wanted to hurt (NNH), clinically related measures that assist present healthcare suppliers with an understanding of the advantages and dangers of UZEDY and inform medical decision-making.
Qualitative knowledge from two ADVANCE (Attitudes Driving Regional Variations in LAI Antipsychotic Utilization for Schizophrenia Amongst Healthcare Professionals, Sufferers, and Caregivers) surveys:
- Within the healthcare supplier survey, ten psychiatrists (spending a mean of 45% of their time at hospital-based outpatient clinics) and 7 psychiatric nurses (averaging 47% of time at group psychological well being facilities) have been interviewed. Findings recommend that regional variations in LAI utilization charges are doubtless influenced by a mixture of things, together with systemic, HCP, and affected person components.
- Within the affected person survey, roughly 20 sufferers and 19 caregivers accomplished a 60-minute interview concerning using LAIs in schizophrenia. Unfavorable early experiences, particularly within the inpatient setting, can negatively influence sufferers’ notion of and willingness to just accept LAIs. The survey findings supply additional key insights into addressing world adherence and inconsistent utilization challenges with LAIs.
Beneath is the complete set of information introduced by Teva at SIRS 2024.
AUSTEDO ® XR (deutetrabenazine):
- (Encore) Occupational Influence of Tardive Dyskinesia (TD): a Cross-Sectional, Worldwide Survey Assessing the Perceptions and Experiences of Sufferers With TD and Physicians Who Deal with TD
- (Encore) Burden and Administration of Tardive Dyskinesia (TD): A Cross-Sectional, Worldwide Survey Research to Assess the Perceptions and Experiences of Physicians and Sufferers With TD
- (De novo) Affected person and Caregiver Experiences With Tardive Dyskinesia: Feelings, Challenges, and Unmet Wants within the Affected person Journey
UZEDY (risperidone):
- (De novo) Switching Sufferers With Schizophrenia to TV-46000, a Lengthy-Appearing Subcutaneous Antipsychotic (LASCA), From Risperidone Microspheres (R064766): An Exploration of Inhabitants Pharmacokinetic (PopPK)“Primarily based Methods
- (De novo) Scientific Profit and Danger Profile of TV-46000 for Sufferers With Schizophrenia as Assessed by Quantity Wanted to Deal with (NNT) and Quantity Wanted to Hurt (NNH)
TV-44749 (olanzapine):
- (De novo) TV-44749, a Lengthy-Appearing Subcutaneous (sc) Injectable Formulation of Olanzapine is Designed to Present Sustained Managed Concentrations and to Get rid of the Causes of Put up-Injection delirium/sedation Syndrome (PDSS)
- (De novo) Inhabitants Pharmacokinetic Modeling Following Administration of Olanzapine for Prolonged-Launch Injectable Suspension (TV-44749) for Subcutaneous Use to Assist Dose Choice for Section 3 Scientific Trial (SOLARIS)
LAI Actual-World Insights:
- (De novo) Attitudes DriVing regional variations in LAI ANtipsychotic utilization for schizophrenia amongst healthcare professionals, sufferers, and CaregivErs (ADVANCE): healthcare skilled qualitative interviews
- (De novo) Attitudes DriVing regional variations in LAI ANtipsychotic utilization for schizophrenia amongst healthcare professionals, sufferers, and CaregivErs (ADVANCE): affected person and caregiver qualitative interviews
- (De novo) Initiation Regimens for Lengthy-Appearing Injectable Antipsychotics Requiring Oral Supplementation: Influence on Subsequent Upkeep Therapy Adherence and Persistence
INDICATION AND USAGE
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for the therapy of schizophrenia in adults.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Aged sufferers with dementia-related psychosis handled with antipsychotic medicine are at an elevated threat of dying. UZEDY is just not permitted to be used in sufferers with dementia-related psychosis and has not been studied on this affected person inhabitants.
See beneath for added Essential Security Info.
TV-44749 (olanzapine) is an investigational extended-release injectable suspension for subcutaneous use and isn’t permitted by any regulatory authority for any use and its security and efficacy should not established.
About Schizophrenia
Schizophrenia is a persistent, progressive and severely debilitating psychological dysfunction that impacts how one thinks, feels and acts.1 Sufferers expertise an array of signs, which can embody delusions, hallucinations, disorganized speech or habits and impaired cognitive capacity.1,2,3 Roughly 1% of the world’s inhabitants will develop schizophrenia of their lifetime, and three.5 million folks within the U.S. are presently identified with the situation.2,3 Though schizophrenia can happen at any age, the typical age of onset tends to be within the late teenagers to the early 20s for males, and the late 20s to early 30s for ladies.3 The long-term course of schizophrenia is marked by episodes of partial or full remission damaged by relapses that always happen within the context of psychiatric emergency and require hospitalization.3 Roughly 80% of sufferers expertise a number of relapses over the primary 5 years of therapy, and every relapse carries a organic threat of lack of operate, therapy refractoriness, and modifications in mind morphology.4,5,6 Sufferers are sometimes unaware of their sickness and its penalties, contributing to therapy nonadherence, excessive discontinuation charges, and finally, vital direct and oblique healthcare prices from subsequent relapses and hospitalizations.1,2,3,4,5,6
About UZEDY
UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use, is indicated for the therapy of schizophrenia in adults. In medical trials, UZEDY considerably lowered the chance of schizophrenia relapse.7,8 UZEDY administers risperidone via copolymer expertise beneath license from MedinCell that enables for absorption and sustained launch after subcutaneous injection. UZEDY is the one long-acting, subcutaneous formulation of risperidone accessible in each one- and two-month dosing intervals.7 For full prescribing data, go to https://www.uzedy.com/globalassets/uzedy/prescribing-information.pdf.
IMPORTANT SAFETY INFORMATION CONTINUED
CONTRAINDICATIONS: UZEDY is contraindicated in sufferers with a recognized hypersensitivity to risperidone, its metabolite, paliperidone, or to any of its parts. Hypersensitivity reactions, together with anaphylactic reactions and angioedema, have been reported in sufferers handled with risperidone or paliperidone.
WARNINGS AND PRECAUTIONS
Cerebrovascular Opposed Reactions: In trials of aged sufferers with dementia-related psychosis, there was a considerably larger incidence of cerebrovascular opposed occasions (e.g., stroke, transient ischemic assault), together with fatalities, in sufferers handled with oral risperidone in comparison with placebo. UZEDY is just not permitted to be used in sufferers with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): NMS, a doubtlessly deadly symptom advanced, has been reported in affiliation with antipsychotic medicine. Scientific manifestations of NMS are hyperpyrexia, muscle rigidity, altered psychological standing together with delirium, and autonomic instability (irregular pulse or blood stress, tachycardia, diaphoresis, and cardiac dysrhythmia). Further indicators could embody elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, instantly discontinue UZEDY and supply symptomatic therapy and monitoring.
Tardive Dyskinesia (TD): TD, a syndrome consisting of probably irreversible, involuntary, dyskinetic actions, could develop in sufferers handled with antipsychotic medicine. Though the prevalence of the syndrome seems to be highest among the many aged, particularly aged ladies, it’s inconceivable to foretell which sufferers will develop the syndrome. Whether or not antipsychotic drug merchandise differ of their potential to trigger TD is unknown.
The chance of creating TD and the probability that it’s going to grow to be irreversible are believed to extend with the period of therapy and the cumulative dose. The syndrome can develop, after comparatively transient therapy durations, even at low doses. It could additionally happen after discontinuation. TD could remit, partially or fully, if antipsychotic therapy is discontinued. Antipsychotic therapy, itself, nonetheless, could suppress (or partially suppress) the indicators and signs of the syndrome, presumably masking the underlying course of. The impact that symptomatic suppression has upon the long-term course of the syndrome is unknown.
If indicators and signs of TD seem in a affected person handled with UZEDY, drug discontinuation needs to be thought-about. Nevertheless, some sufferers could require therapy with UZEDY regardless of the presence of the syndrome. In sufferers who do require persistent therapy, use the bottom dose and the shortest period of therapy producing a passable medical response. Periodically reassess the necessity for continued therapy.
Metabolic Adjustments: Atypical antipsychotic medicine have been related to metabolic modifications which will enhance cardiovascular/cerebrovascular threat. These metabolic modifications embody hyperglycemia, dyslipidemia, and physique weight acquire. Whereas the entire medicine within the class have been proven to supply some metabolic modifications, every drug has its personal particular threat profile.
Hyperglycemia and diabetes mellitus (DM), in some instances excessive and related to ketoacidosis or hyperosmolar coma or dying, have been reported in sufferers handled with atypical antipsychotics, together with risperidone. Sufferers with a longtime prognosis of DM who’re began on atypical antipsychotics, together with UZEDY, needs to be monitored often for worsening of glucose management. Sufferers with threat components for DM (e.g., weight problems, household historical past of diabetes) who’re beginning therapy with atypical antipsychotics, together with UZEDY, ought to bear fasting blood glucose (FBG) testing at first of therapy and periodically throughout therapy. Any affected person handled with atypical antipsychotics, together with UZEDY, needs to be monitored for signs of hyperglycemia together with polydipsia, polyuria, polyphagia, and weak point. Sufferers who develop signs of hyperglycemia throughout therapy with atypical antipsychotics, together with UZEDY, ought to bear FBG testing. In some instances, hyperglycemia has resolved when the atypical antipsychotic, together with risperidone, was discontinued; nonetheless, some sufferers required continuation of antidiabetic therapy regardless of discontinuation of risperidone.
Dyslipidemia has been noticed in sufferers handled with atypical antipsychotics.
Weight acquire has been noticed with atypical antipsychotic use. Monitoring weight is advisable.
Hyperprolactinemia: As with different medicine that antagonize dopamine D2 receptors, risperidone elevates prolactin ranges and the elevation persists throughout persistent administration. Risperidone is related to larger ranges of prolactin elevation than different antipsychotic brokers.
Orthostatic Hypotension and Syncope: UZEDY could induce orthostatic hypotension related to dizziness, tachycardia, and in some sufferers, syncope. UZEDY needs to be used with explicit warning in sufferers with recognized heart problems, cerebrovascular illness, and situations which might predispose sufferers to hypotension and within the aged and sufferers with renal or hepatic impairment. Monitoring of orthostatic very important indicators needs to be thought-about in all such sufferers, and a dose discount needs to be thought-about if hypotension happens. Clinically vital hypotension has been noticed with concomitant use of oral risperidone and antihypertensive treatment.
Falls: Antipsychotics, together with UZEDY, could trigger somnolence, postural hypotension, motor and sensory instability, which can result in falls and, consequently, fractures or different fall-related accidents. Somnolence, postural hypotension, motor and sensory instability have been reported with using risperidone. For sufferers, significantly the aged, with illnesses, situations, or medicines that might exacerbate these results, assess the chance of falls when initiating antipsychotic therapy and recurrently for sufferers on long-term antipsychotic remedy.
Leukopenia, Neutropenia, and Agranulocytosis have been reported with antipsychotic brokers, together with risperidone. In sufferers with a pre-existing historical past of a clinically vital low white blood cell rely (WBC) or absolute neutrophil rely (ANC) or a historical past of drug-induced leukopenia or neutropenia, carry out a whole blood rely (CBC) incessantly through the first few months of remedy. In such sufferers, contemplate discontinuation of UZEDY on the first signal of a clinically vital decline in WBC within the absence of different causative components. Monitor sufferers with clinically vital neutropenia for fever or different signs or indicators of an infection and deal with promptly if such signs or indicators happen. Discontinue UZEDY in sufferers with ANC < 1000/mm3) and observe their WBC till restoration.
Potential for Cognitive and Motor Impairment: UZEDY, like different antipsychotics, could trigger somnolence and has the potential to impair judgement, considering, and motor expertise. Somnolence was a generally reported opposed response related to oral risperidone therapy. Warning sufferers about working hazardous equipment, together with motor automobiles, till they’re moderately sure that therapy with UZEDY doesn’t have an effect on them adversely.
Seizures: Throughout premarketing research of oral risperidone in grownup sufferers with schizophrenia, seizures occurred in 0.3% of sufferers (9 out of two,607 sufferers), two in affiliation with hyponatremia. Use UZEDY cautiously in sufferers with a historical past of seizures or different situations that doubtlessly decrease the seizure threshold.
Dysphagia: Esophageal dysmotility and aspiration have been related to antipsychotic drug use. Antipsychotic medicine, together with UZEDY, needs to be used cautiously in sufferers in danger for aspiration.
Priapism has been reported throughout postmarketing surveillance for different risperidone merchandise. A case of priapism was reported in premarket research of UZEDY. Extreme priapism could require surgical intervention.
Physique temperature regulation. Disruption of the physique’s capacity to scale back core physique temperature has been attributed to antipsychotic brokers. Each hyperthermia and hypothermia have been reported in affiliation with oral risperidone use. Strenuous train, publicity to excessive warmth, dehydration, and anticholinergic medicines could contribute to an elevation in core physique temperature; use UZEDY with warning in sufferers who expertise these situations.
ADVERSE REACTIONS
The most typical opposed reactions with risperidone ( ‰¥5% and higher than placebo) have been parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, nervousness, blurred imaginative and prescient, nausea, vomiting, higher belly ache, abdomen discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, elevated urge for food, elevated weight, fatigue, rash, nasal congestion, higher respiratory tract an infection, nasopharyngitis, and pharyngolaryngeal ache.
The most typical injection web site reactions with UZEDY ( ‰¥5% and higher than placebo) have been pruritus and nodule.
DRUG INTERACTIONS
- Carbamazepine and different robust CYP3A4 inducers lower plasma concentrations of risperidone.
- Fluoxetine, paroxetine, and different robust CYP2D6 inhibitors enhance risperidone plasma focus.
- Attributable to additive pharmacologic results, the concomitant use of centrally-acting medicine, together with alcohol, could enhance nervous system problems.
- UZEDY could improve the hypotensive results of different therapeutic brokers with this potential.
- UZEDY could antagonize the pharmacologic results of dopamine agonists.
- Concomitant use with methylphenidate, when there may be change in dosage of both treatment, could enhance the chance of extrapyramidal signs (EPS)
USE IN SPECIFIC POPULATIONS
Being pregnant: Could trigger EPS and/or withdrawal signs in neonates with third trimester publicity. There’s a being pregnant publicity registry that screens being pregnant outcomes in ladies uncovered to atypical antipsychotics, together with UZEDY, throughout being pregnant. Healthcare suppliers are inspired to register sufferers by contacting the Nationwide Being pregnant Registry for Atypical Antipsychotics at 1-866-961-2388 or on-line at http://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/.
Lactation: Infants uncovered to risperidone via breastmilk needs to be monitored for extra sedation, failure to thrive, jitteriness, and EPS.
Fertility: UZEDY could trigger a reversible discount in fertility in females.
Pediatric Use: Security and effectiveness of UZEDY haven’t been established in pediatric sufferers.
Renal or Hepatic Impairment: Rigorously titrate on oral risperidone as much as a minimum of 2 mg every day earlier than initiating therapy with UZEDY.
Sufferers with Parkinson’s illness or dementia with Lewy our bodies can expertise elevated sensitivity to UZEDY. Manifestations and options are in step with NMS.
Please see the complete Prescribing Info for UZEDY, together with Boxed WARNING.
About AUSTEDO ® XR Prolonged-Launch Tablets and AUSTEDO ® Tablets
AUSTEDO XR and AUSTEDO are the primary vesicular monoamine transporter 2 (VMAT2) inhibitors permitted by the U.S. Meals and Drug Administration in adults for the therapy of tardive dyskinesia and for the therapy of chorea related to Huntington’s illness. Security and effectiveness in pediatric sufferers haven’t been established. AUSTEDO XR is the once-daily formulation of AUSTEDO.
INDICATIONS AND USAGE
AUSTEDO ® XR (deutetrabenazine) extended-release tablets and AUSTEDO ® (deutetrabenazine) tablets are indicated in adults for the therapy of chorea related to Huntington’s illness and for the therapy of tardive dyskinesia.
IMPORTANT SAFETY INFORMATION
Melancholy and Suicidality in Sufferers with Huntington’s Illness: AUSTEDO XR and AUSTEDO can enhance the chance of melancholy and suicidal ideas and habits (suicidality) in sufferers with Huntington’s illness. Steadiness the dangers of melancholy and suicidality with the medical want for therapy of chorea. Intently monitor sufferers for the emergence or worsening of melancholy, suicidality, or uncommon modifications in habits. Inform sufferers, their caregivers, and households of the chance of melancholy and suicidality and instruct them to report behaviors of concern promptly to the treating doctor. Train warning when treating sufferers with a historical past of melancholy or prior suicide makes an attempt or ideation. AUSTEDO XR and AUSTEDO are contraindicated in sufferers who’re suicidal, and in sufferers with untreated or inadequately handled melancholy.
Contraindications: AUSTEDO XR and AUSTEDO are contraindicated in sufferers with Huntington’s illness who’re suicidal, or have untreated or inadequately handled melancholy. AUSTEDO XR and AUSTEDO are additionally contraindicated in: sufferers with hepatic impairment; sufferers taking reserpine or inside 20 days of discontinuing reserpine; sufferers taking monoamine oxidase inhibitors (MAOIs), or inside 14 days of discontinuing MAOI remedy; and sufferers taking tetrabenazine or valbenazine.
Scientific Worsening and Opposed Occasions in Sufferers with Huntington’s Illness: AUSTEDO XR and AUSTEDO could trigger a worsening in temper, cognition, rigidity, and practical capability. Prescribers ought to periodically re-evaluate the necessity for AUSTEDO XR or AUSTEDO of their sufferers by assessing the impact on chorea and attainable opposed results.
QTc Prolongation: AUSTEDO XR and AUSTEDO could extend the QT interval, however the diploma of QT prolongation is just not clinically vital when AUSTEDO XR or AUSTEDO is run throughout the advisable dosage vary. AUSTEDO XR and AUSTEDO needs to be prevented in sufferers with congenital lengthy QT syndrome and in sufferers with a historical past of cardiac arrhythmias.
Neuroleptic Malignant Syndrome (NMS), a doubtlessly deadly symptom advanced reported in affiliation with medicine that scale back dopaminergic transmission, has been noticed in sufferers receiving tetrabenazine. The chance could also be elevated by concomitant use of dopamine antagonists or antipsychotics. The administration of NMS ought to embody speedy discontinuation of AUSTEDO XR and AUSTEDO; intensive symptomatic therapy and medical monitoring; and therapy of any concomitant severe medical issues.
Akathisia, Agitation, and Restlessness: AUSTEDO XR and AUSTEDO could enhance the chance of akathisia, agitation, and restlessness. The chance of akathisia could also be elevated by concomitant use of dopamine antagonists or antipsychotics. If a affected person develops akathisia, the AUSTEDO XR or AUSTEDO dose needs to be lowered; some sufferers could require discontinuation of remedy.
Parkinsonism: AUSTEDO XR and AUSTEDO could trigger parkinsonism in sufferers with Huntington’s illness or tardive dyskinesia. Parkinsonism has additionally been noticed with different VMAT2 inhibitors. The chance of parkinsonism could also be elevated by concomitant use of dopamine antagonists or antipsychotics. If a affected person develops parkinsonism, the AUSTEDO XR or AUSTEDO dose needs to be lowered; some sufferers could require discontinuation of remedy.
Sedation and Somnolence: Sedation is a standard dose-limiting opposed response of AUSTEDO XR and AUSTEDO. Sufferers mustn’t carry out actions requiring psychological alertness, corresponding to working a motorcar or hazardous equipment, till they’re on a upkeep dose of AUSTEDO XR or AUSTEDO and know the way the drug impacts them. Concomitant use of alcohol or different sedating medicine could have additive results and worsen sedation and somnolence.
Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in people. If there’s a medical suspicion of symptomatic hyperprolactinemia, acceptable laboratory testing needs to be performed and consideration needs to be given to discontinuation of AUSTEDO XR and AUSTEDO.
Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and will accumulate in these tissues over time. Prescribers ought to pay attention to the potential of long-term ophthalmologic results.
Widespread Opposed Reactions: The most typical opposed reactions for AUSTEDO (>8% and higher than placebo) in a managed medical research in sufferers with Huntington’s illness have been somnolence, diarrhea, dry mouth, and fatigue. The most typical opposed reactions for AUSTEDO (4% and higher than placebo) in managed medical research in sufferers with tardive dyskinesia have been nasopharyngitis and insomnia. Opposed reactions with AUSTEDO XR extended-release tablets are anticipated to be just like AUSTEDO tablets.
Please see accompanying full Prescribing Info, together with Boxed Warning.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a worldwide pharmaceutical chief with a category-defying portfolio, harnessing our generics experience and stepping up innovation to proceed the momentum behind the invention, supply, and expanded growth of contemporary medication. For over 120 years, Teva’s dedication to bettering well being has by no means wavered. In the present day, the corporate’s world community of capabilities permits its 37,000 staff throughout 58 markets to push the boundaries of scientific innovation and ship high quality medicines to assist enhance well being outcomes of tens of millions of sufferers on daily basis. To study extra about how Teva is all in for higher well being, go to www.tevapharm.com.
Cautionary Be aware Concerning Ahead-Trying Statements
This press launch incorporates forward-looking statements throughout the that means of the Personal Securities Litigation Reform Act of 1995, that are primarily based on administration’s present beliefs and expectations and are topic to substantial dangers and uncertainties, each recognized and unknown, that might trigger our future outcomes, efficiency or achievements to vary considerably from that expressed or implied by such forward-looking statements. You’ll be able to determine these forward-looking statements by way of phrases corresponding to ought to, anticipate, anticipate, estimate, goal, could, undertaking, steering, intend, plan, imagine and different phrases and phrases of comparable that means and expression in reference to any dialogue of future working or monetary efficiency. Essential components that might trigger or contribute to such variations embody dangers referring to: our capacity to efficiently develop and commercialize UZEDY; our capacity to efficiently develop and commercialize AUSTEDO XR; our capacity to develop and acquire regulatory approvals to our late-stage pipeline belongings, together with olanzapine LAI (TEV-˜749); our capacity to efficiently execute our Pivot to Progress technique, together with to broaden our revolutionary and biosimilar medicines pipeline and profitably commercialize the revolutionary medicines and biosimilar portfolio, whether or not organically or via enterprise growth; and different components mentioned on this press launch, and in our Annual Report on Kind 10-Okay for the 12 months ended December 31, 2023, together with within the sections captioned “Danger Components. Ahead-looking statements converse solely as of the date on which they’re made, and we assume no obligation to replace or revise any forward-looking statements or different data contained herein, whether or not on account of new data, future occasions or in any other case. You might be cautioned to not put undue reliance on these forward-looking statements.
________
1 Substance Abuse and Psychological Well being Companies Administration. Schizophrenia. https://www.samhsa.gov/mental-health/schizophrenia. Accessed November 2023.
2 Velligan DI, Rao S. The epidemiology and world burden of schizophrenia. J Clin Psychiatry. 2023;84(1):MS21078COM5. https://doi.org/10.4088/JCP.MS21078COM5.
3 Wander C. (2020). Schizophrenia: alternatives to enhance outcomes and scale back financial burden via managed care. The American journal of managed care, 26(3 Suppl), S62“S68. https://doi.org/10.37765/ajmc.2020.43013
4 Emsley, R., & Kilian, S. (2018). Efficacy and security profile of paliperidone palmitate injections within the administration of sufferers with schizophrenia: an evidence-based assessment. Neuropsychiatric illness and therapy, 14, 205“223.
5 Emsley, R., Chiliza, B., Asmal, L. et al. (2013) The character of relapse in schizophrenia. BMC Psychiatry 13, 50.
6 Andreasen, N. C., et al. (2013). Relapse period, therapy depth, and mind tissue loss in schizophrenia: a potential longitudinal MRI research. The American journal of psychiatry, 170(6), 609“615.
7 UZEDY™ (risperidone) extended-release injectable suspension, for subcutaneous injection Present Prescribing Info. Parsippany, NJ. Teva Neuroscience, Inc.
8 Knowledge on file. Parsippany, NJ: Teva Neuroscience, Inc.
View supply model on businesswire.com: https://www.businesswire.com/information/dwelling/20240406098130/en/
IR
Ran Meir
+1 (267) 468-4475
Yael Ashman
+972 (3) 914 8262
Sanjeev Sharma
+1 (973) 658 2700
PR
Kelley Dougherty
+1 (973) 832-2810
Eden Klein
+972 (3) 906 2645
Supply: Teva Pharmaceutical Industries Restricted
