DUBLIN, Could 3, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) right now introduced plans to current medical knowledge and outcomes analysis from its psychiatry portfolio at three scientific conferences throughout Psychological Well being Consciousness Month in Could. The conferences, all held just about, embrace:
- American Psychiatric Affiliation (APA) Annual Assembly, Could 1-3;
- Worldwide Society for Bipolar Issues (ISBD) Annual Convention, Could 13-15;
- Worldwide Society for Pharmacoeconomics and Outcomes Analysis (ISPOR) Annual Assembly, Could 17-20.
“We’re happy to share new analysis at these necessary conferences, which coincide with Psychological Well being Consciousness Month, a month devoted to elevating consciousness about psychological sickness and serving to to scale back stigma usually related to these complicated circumstances,” mentioned Craig Hopkinson, M.D., Government Vice President, Analysis & Improvement and Chief Medical Officer at Alkermes. “The outcomes knowledge we’re presenting this month assist to advance our understanding of the real-world experiences of individuals dwelling with schizophrenia or bipolar I dysfunction, as we search to develop potential new medicines for folks dwelling with critical psychological sickness.”
Highlights of the upcoming displays embrace:
- A medical overview of olanzapine/samidorphan (LYBALVI™), previously known as ALKS 3831, consisting of 18 medical research, together with 10 section 1, two section 2 and 6 section 3 research, evaluating the investigational compound’s antipsychotic efficacy and weight mitigation profile, together with pharmacokinetics, security and tolerability.
- Outcomes from a retrospective evaluation of digital well being information and claims knowledge assessing clinically-significant weight achieve and comorbidities noticed in sufferers with schizophrenia or bipolar I dysfunction after initiating choose second-generation antipsychotics.
- Findings from a retrospective evaluation of digital medical information evaluating remedy and prescribing patterns amongst sufferers with schizophrenia who initiated remedy with ARISTADA® (aripiprazole lauroxil) versus different atypical long-acting injectable antipsychotics.
The complete record of Alkermes’ displays by assembly consists of:
- #P11-068: A Mixture of Olanzapine and Samidorphan in Adults With Schizophrenia and Bipolar I Dysfunction: Overview of Medical Knowledge, shall be offered throughout poster session II Monday, Could 3 from 1:30 – 2:00 p.m. ET
- #S15: Weight Achieve and Comorbidities Related With Oral Second-Era Antipsychotics: Evaluation of Actual-World Knowledge for Sufferers With Bipolar I Dysfunction or Schizophrenia, shall be offered Saturday, Could 15 from 5:00 – 6:30 pm ET
- #S37: A Mixture of Olanzapine and Samidorphan in Adults With Schizophrenia and Bipolar I Dysfunction: Overview of Medical Knowledge, shall be offered Saturday, Could 15 from 5:00 – 6:30 p.m. ET
- #PMH46: Therapy Patterns With Aripiprazole Lauroxil Versus Different Atypical Lengthy-Performing Injectable Antipsychotics in Sufferers With Schizophrenia: A Retrospective Digital Well being Information Database Examine, shall be offered Wednesday, Could 19 from 11:30 a.m. – 1:45 p.m. ET
About olanzapine/samidorphan (LYBALVI™)LYBALVI is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the remedy of adults with schizophrenia and for the remedy of adults with bipolar I dysfunction. LYBALVI consists of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer pill.
About ARISTADA® ARISTADA is an injectable atypical antipsychotic authorised in 4 doses and three dosing durations for the remedy of schizophrenia (441 mg, 662 mg or 882 mg month-to-month, 882 mg as soon as each six weeks and 1064 mg as soon as each two months). As soon as within the physique, ARISTADA converts to aripiprazole.
About ARISTADA INITIO®ARISTADA INITIO, together with a single 30 mg dose of oral aripiprazole, can be utilized to provoke onto any dose of ARISTADA. The primary ARISTADA dose could also be administered on the identical day because the ARISTADA INITIO routine or as much as 10 days thereafter.
INDICATION and IMPORTANT SAFETY INFORMATION for ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use
ARISTADA INITIO, together with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the remedy of schizophrenia in adults.
ARISTADA is indicated for the remedy of schizophrenia in adults.
IMPORTANT SAFETY INFORMATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Aged sufferers with dementia-related psychosis handled with antipsychotic medication are at an elevated danger of demise. ARISTADA INITIO and ARISTADA usually are not authorised for the remedy of sufferers with dementia-related psychosis.
Contraindication: Identified hypersensitivity response to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.
Cerebrovascular Hostile Reactions, Together with Stroke: Elevated incidence of cerebrovascular adversarial reactions (e.g., stroke, transient ischemic assault), together with fatalities, have been reported in placebo-controlled trials of aged sufferers with dementia-related psychosis handled with risperidone, aripiprazole, and olanzapine. ARISTADA INITIO and ARISTADA usually are not authorised for the remedy of sufferers with dementia-related psychosis.
Potential for Dosing and Medicine Errors: Medicine errors, together with substitution and shelling out errors, between ARISTADA INITIO and ARISTADA may happen. ARISTADA INITIO is meant for single administration in distinction to ARISTADA which is run month-to-month, each 6 weeks, or each 8 weeks. Don’t substitute ARISTADA INITIO for ARISTADA due to differing pharmacokinetic profiles.
Neuroleptic Malignant Syndrome (NMS): A doubtlessly deadly symptom complicated might happen with administration of antipsychotic medication, together with ARISTADA INITIO and ARISTADA. Medical manifestations of NMS embrace hyperpyrexia, muscle rigidity, altered psychological standing, and proof of autonomic instability (irregular pulse or blood stress, tachycardia, diaphoresis, and cardiac dysrhythmia). Extra indicators might embrace elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The administration of NMS ought to embrace: 1) speedy discontinuation of antipsychotic medication and different medication not important to concurrent remedy; 2) intensive symptomatic remedy and medical monitoring; and three) remedy of any concomitant critical medical issues for which particular remedies can be found.
Tardive Dyskinesia (TD): The danger of growing TD (a syndrome of irregular, involuntary actions) and the potential for it to change into irreversible are believed to extend because the length of remedy and the full cumulative dose of antipsychotic improve. The syndrome can develop, though a lot much less generally, after comparatively temporary remedy durations at low doses. Prescribing antipsychotics needs to be in step with the necessity to decrease TD. Discontinue ARISTADA if clinically applicable. TD might remit, partially or fully, if antipsychotic remedy is withdrawn.
Metabolic Modifications: Atypical antipsychotic medication have been related to metabolic modifications that embrace:
- Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some circumstances excessive and related to ketoacidosis, coma, or demise, has been reported in sufferers handled with atypical antipsychotics. There have been stories of hyperglycemia in sufferers handled with oral aripiprazole. Sufferers with diabetes needs to be commonly monitored for worsening of glucose management; these with danger elements for diabetes ought to endure baseline and periodic fasting blood glucose testing. Any affected person handled with atypical antipsychotics needs to be monitored for signs of hyperglycemia, together with polydipsia, polyuria, polyphagia, and weak spot. Sufferers who develop signs of hyperglycemia also needs to endure fasting blood glucose testing. In some circumstances, hyperglycemia has resolved when the atypical antipsychotic was discontinued; nonetheless, some sufferers require continuation of antidiabetic remedy regardless of discontinuation of the suspect drug.
- Dyslipidemia: Undesirable alterations in lipids have been noticed in sufferers handled with atypical antipsychotics.
- Weight Achieve: Weight achieve has been noticed with atypical antipsychotic use. Medical monitoring of weight is beneficial.
Pathological Playing and Different Compulsive Behaviors: Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Different compulsive urges much less continuously reported embrace sexual urges, buying, binge consuming and different impulsive or compulsive behaviors which can lead to hurt for the affected person and others if not acknowledged. Carefully monitor sufferers and think about dose discount or stopping aripiprazole if a affected person develops such urges.
Orthostatic Hypotension: Aripiprazole might trigger orthostatic hypotension which will be related to dizziness, lightheadedness, and tachycardia. Monitor coronary heart price and blood stress, and warn sufferers with identified cardiovascular or cerebrovascular illness and danger of dehydration and syncope.
Falls: Antipsychotics together with ARISTADA INITIO and ARISTADA might trigger somnolence, postural hypotension or motor and sensory instability which can result in falls and subsequent harm. Upon initiating remedy and recurrently, full fall danger assessments as applicable.
Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor full blood rely in sufferers with pre-existing low white blood cell rely (WBC)/absolute neutrophil rely or historical past of drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO and/or ARISTADA on the first signal of a clinically vital decline in WBC and in severely neutropenic sufferers.
Seizures: Use with warning in sufferers with a historical past of seizures or with circumstances that decrease the seizure threshold.
Potential for Cognitive and Motor Impairment: ARISTADA INITIO and ARISTADA might impair judgment, pondering, or motor expertise. Sufferers needs to be cautioned about working hazardous equipment, together with cars, till they’re sure remedy with ARISTADA INITIO and/or ARISTADA doesn’t have an effect on them adversely.
Physique Temperature Regulation: Disruption of the physique’s capability to scale back core physique temperature has been attributed to antipsychotic brokers. Advise sufferers relating to applicable care in avoiding overheating and dehydration. Acceptable care is suggested for sufferers who might train strenuously, could also be uncovered to excessive warmth, obtain concomitant remedy with anticholinergic exercise, or are topic to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been related to antipsychotic drug use; use warning in sufferers in danger for aspiration pneumonia.
Concomitant Medicine: ARISTADA INITIO is simply obtainable at a single power as a single-dose pre-filled syringe, so dosage changes usually are not potential. Keep away from use in sufferers who’re identified CYP2D6 poor metabolizers or taking robust CYP3A4 inhibitors, robust CYP2D6 inhibitors, or robust CYP3A4 inducers, antihypertensive medication or benzodiazepines.
Relying on the ARISTADA dose, changes could also be beneficial if sufferers are 1) often called CYP2D6 poor metabolizers and/or 2) taking robust CYP3A4 inhibitors, robust CYP2D6 inhibitors, or robust CYP3A4 inducers for larger than 2 weeks. Keep away from use of ARISTADA 662 mg, 882 mg, or 1064 mg for sufferers taking each robust CYP3A4 inhibitors and robust CYP2D6 inhibitors. (See Desk 4 within the ARISTADA full Prescribing Data.)
Generally Noticed Hostile Reactions: In pharmacokinetic research the protection profile of ARISTADA INITIO was typically in step with that noticed for ARISTADA. The most typical adversarial response (≥5% incidence and at the least twice the speed of placebo reported by sufferers handled with ARISTADA 441 mg and 882 mg month-to-month) was akathisia.
Injection-Web site Reactions: In pharmacokinetic research evaluating ARISTADA INITIO, the incidences of injection web site reactions with ARISTADA INITIO had been much like the incidence noticed with ARISTADA. Injection-site reactions had been reported by 4%, 5%, and a pair of% of sufferers handled with 441 mg ARISTADA (month-to-month), 882 mg ARISTADA (month-to-month), and placebo, respectively. Most of those had been injection-site ache and related to the primary injection and decreased with every subsequent injection. Different injection-site reactions (induration, swelling, and redness) occurred at lower than 1%.
Dystonia: Signs of dystonia, extended irregular contractions of muscle teams, might happen in inclined people in the course of the first days of remedy and at low doses.
Being pregnant/Nursing: Could trigger extrapyramidal and/or withdrawal signs in neonates with third trimester publicity. Advise sufferers to inform their healthcare supplier of a identified or suspected being pregnant. Inform sufferers that there’s a being pregnant publicity registry that displays being pregnant outcomes in ladies uncovered to ARISTADA INITIO and/or ARISTADA throughout being pregnant. Aripiprazole is current in human breast milk. The advantages of breastfeeding needs to be thought of together with the mom’s medical want for ARISTADA INITIO and/or ARISTADA and any potential adversarial results on the toddler from ARISTADA INITIO and/or ARISTADA or from the underlying maternal situation.
About AlkermesAlkermes plc is a fully-integrated, international biopharmaceutical firm growing modern medicines within the fields of neuroscience and oncology. The corporate has a portfolio of proprietary business merchandise centered on habit and schizophrenia, and a pipeline of product candidates in growth for schizophrenia, bipolar I dysfunction, neurodegenerative issues, and most cancers. Headquartered in Dublin, Eire, Alkermes plc has an R&D heart in Waltham, Massachusetts; a analysis and manufacturing facility in Athlone, Eire; and a producing facility in Wilmington, Ohio. For extra data, please go to Alkermes’ web site at www.alkermes.com.
Notice Concerning Ahead-Wanting StatementsSure statements set forth on this press launch represent “forward-looking statements” throughout the which means of the Non-public Securities Litigation Reform Act of 1995, as amended, together with, however not restricted to, statements in regards to the potential therapeutic worth of ARISTADA and LYBALVI and the corporate’s capability to develop new medicines for folks dwelling with critical psychological sickness. The corporate cautions that forward-looking statements are inherently unsure. Though the corporate believes that such statements are primarily based on affordable assumptions throughout the bounds of its information of its enterprise and operations, the forward-looking statements are neither guarantees nor ensures and they’re essentially topic to a excessive diploma of uncertainty and danger. Precise efficiency and outcomes might differ materially from these expressed or implied within the forward-looking statements as a result of varied dangers and uncertainties. These dangers and uncertainties embrace, amongst others: whether or not the outcomes of the corporate’s medical growth actions and outcomes analysis are predictive of real-world outcomes or of leads to subsequent medical trials, analyses or analysis; whether or not the corporate can efficiently develop, and acquire U.S. Meals and Drug Administration (“FDA”) approval of, new medicines for folks dwelling with critical psychological sickness, together with LYBALVI; potential modifications in the fee, scope or timelines for growth or regulatory actions for the corporate’s merchandise and product candidates, together with modifications regarding the COVID-19 pandemic; and people dangers described within the Alkermes plc Annual Report on Type 10-Okay for the 12 months ended Dec. 31, 2020 and in subsequent filings made by the corporate with the U.S. Securities and Change Fee (SEC), which can be found on the SEC’s web site at www.sec.gov. The data contained on this press launch is offered by the corporate as of the date hereof, and, besides as required by legislation, the corporate disclaims any intention or duty for updating or revising any forward-looking data contained on this press launch.
ARISTADA® and ARISTADA INITIO® are registered logos of Alkermes Pharma Eire Restricted; LYBALVITM is a trademark of Alkermes Pharma Eire Restricted.
Alkermes Contacts:For Buyers: Sandy Coombs +1 781 609 6377For Media: Marisa Borgasano +1 781 609 6659
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