Alkermes Presents Clinical and Real-World Data at 36th Annual Psych Congress

— Poster Presentations Highlight Company's Broad Research Commitment to Serious Mental Illness, Addiction and Narcolepsy —

DUBLIN, Sept. 11, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced the presentation of multiple posters highlighting real-world and clinical data at the 36th Annual Psych Congress (Psych Congress), which took place Sept. 6-10, 2023 in Nashville. This research reflects the company's continued commitment to improving care for, and understanding the unique needs of, people living with serious chronic diseases.

"Psych Congress offers an important opportunity for scientific exchange and information sharing as we seek to advance care for people living with serious, complex diseases. This year's presentations further reinforce Alkermes' leadership and experience in the field of neuroscience," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.

Highlights of the presentations include:

• The first real-world data assessment of healthcare resource use in patients with schizophrenia or bipolar I disorder in the six months following initiation of LYBALVI® (olanzapine and samidorphan);
• Findings from a meta-analysis using individual subject-level data across three randomized, double-blind, controlled clinical trials designed to assess changes in body weight as either a primary or secondary endpoint in patients who received LYBALVI compared to those who received olanzapine;
• Three posters describing the first set of results from OASIS (Observational Study of Long-Acting Injectables in Schizophrenia), a prospective, noninterventional study evaluating the use of second-generation long-acting injectables (LAIs) in community clinics, including during the COVID-19 pandemic;
• Post-hoc analyses of the ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study, in which patients with schizophrenia were randomized to receive either the two-month dose of ARISTADA® (aripiprazole lauroxil) initiated in an inpatient setting using ARISTADA INITIO® (aripiprazole lauroxil) plus a single 30 mg oral dose of olanzapine, or an active control of paliperidone palmitate; and
• Results from a recently completed, structured qualitative interview study evaluating the diagnosis journey and symptoms of adults living with narcolepsy type 1 and narcolepsy type 2.

A full list of Alkermes' presentations at Psych Congress follows:

• Poster #18: Diagnosis and Symptoms of Narcolepsy from the Patient Perspective: Results from In-Depth Qualitative Interviews
• Poster #86: Aripiprazole Lauroxil 2-Month Formulation for Acute Schizophrenia: A Post Hoc Analysis of PANSS Factor Scores in the ALPINE Study
• Poster #88: Key Characteristics of the Atypical Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil for the Treatment of Schizophrenia
• Poster #91: Olanzapine/Samidorphan Effects on Weight Gain: A Meta-analysis of Phase 2 and 3 Randomized, Double-Blind Studies
• Poster #147: Burden of Bipolar I Disorder on Clinical, Economic, and Humanistic Outcomes: Matched Analysis of US National Health and Wellness Survey Data
• Poster #148: Healthcare Resource Utilization Following 6 Months of Treatment With Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia or Bipolar I Disorder
• Poster #157: Baseline Demographics and Clinical Characteristics From OASIS: An Observational Study of Long-Acting Injectables in Schizophrenia
• Poster #161: Treatment Patterns From OASIS: Observational Study of Long-Acting Injectables in Schizophrenia
• Poster #163: Outcomes From OASIS: Observational Study of Long-Acting Injectables in Schizophrenia
• Poster #158: Mental Health Comorbidities Among Patients With Chronic Medical Conditions and Alcohol Use Disorder
• Poster #159: Opioid Antagonists: Clinical Utility, Pharmacology, and Safety and Tolerability

About LYBALVI® (olanzapine and samidorphan)LYBALVI® (olanzapine and samidorphan) is a once-daily, oral atypical antipsychotic drug approved in the U.S. for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate. LYBALVI is a combination of olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist in a single bilayer tablet. LYBALVI is available in fixed dosage strengths composed of 10 mg of samidorphan and 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.

IMPORTANT SAFETY INFORMATION FOR LYBALVI® (olanzapine and samidorphan)

Contraindications: LYBALVI is contraindicated in patients who are using opioids or are undergoing acute opioid withdrawal. If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for the contraindications for these products.

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke, transient ischemia attack, and fatalities. See Boxed Warning above.

Precipitation of Severe Opioid Withdrawal in Patients who are Physiologically Dependent on Opioids: LYBALVI can precipitate opioid withdrawal in patients who are dependent on opioids, which can lead to an opioid withdrawal syndrome, sometimes requiring hospitalization. LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Prior to initiating LYBALVI, there should be at least a 7-day opioid-free interval from last use of short-acting opioids, and at least a 14-day opioid-free interval from the last use of long-acting opioids. Explain the risks associated with precipitated withdrawal and the importance of giving an accurate account of last opioid use to patients and caregivers.

Vulnerability to Life-Threatening Opioid Overdose: Attempting to overcome opioid blockade with high or repeated doses of exogenous opioids could lead to life-threatening or fatal opioid intoxication, particularly if LYBALVI therapy is interrupted or discontinued subjecting the patient to high levels of unopposed opioid agonist as the samidorphan blockade wanes. Inform patients of the potential consequences of trying to overcome the opioid blockade and the serious risks of taking opioids concurrently with LYBALVI or while transitioning off LYBALVI. In emergency situations, if a LYBALVI-treated patient requires opioid treatment as part of anesthesia or analgesia, discontinue LYBALVI. Opioids should be administered by properly trained individual(s) and patient should be continuously monitored in a setting equipped and staffed for cardiopulmonary resuscitation. Patients with a history of chronic opioid use prior to treatment with LYBALVI may have decreased opioid tolerance if LYBALVI therapy is interrupted or discontinued. Advise patients that this decreased tolerance may increase the risk of opioid overdose if opioids are resumed at the previously tolerated dosage.

Neuroleptic Malignant Syndrome, a potentially fatal reaction. Signs and symptoms include hyperpyrexia, muscle rigidity, delirium, autonomic instability, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Manage with immediate discontinuation, intensive symptomatic treatment, and close monitoring.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a potentially fatal condition reported with exposure to olanzapine, a component of LYBALVI. Symptoms include a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue if DRESS is suspected.

Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Any patient treated with LYBALVI should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required anti-diabetic treatment despite discontinuation of the suspect drug. Measure weight and assess fasting glucose and lipids when initiating LYBALVI and monitor periodically.

Tardive Dyskinesia (TD): Risk of developing TD (a syndrome of potentially irreversible, involuntary, dyskinetic movements) and the likelihood it will become irreversible increases with the duration of treatment and the cumulative dose. The syndrome can develop after a relatively brief treatment period, even at low doses, or after discontinuation. Given these considerations, LYBALVI should be prescribed in a manner that is most likely to reduce the risk of tardive dyskinesia. If signs and symptoms of TD appear, drug discontinuation should be considered.

Orthostatic Hypotension and Syncope: Monitor orthostatic vital signs in patients who are vulnerable to hypotension, patients with known cardiovascular disease, and patients with cerebrovascular disease. 

Falls: LYBALVI may cause somnolence, postural hypotension, and motor and sensory instability, which may lead to falls, and consequently, fractures or other injuries. Assess patients for risk when using LYBALVI.

Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases): Perform complete blood counts in patients with a history of a clinically significant low white blood cell (WBC) count or history of leukopenia or neutropenia. Discontinue LYBALVI if clinically significant decline in WBC occurs in the absence of other causative factors.

Dysphagia: Use LYBALVI with caution in patients at risk for aspiration.

Seizures: Use LYBALVI with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: Because LYBALVI may cause somnolence, impair judgment, thinking, or motor skills, caution patients about operating hazardous machinery, including motor vehicles, until they are certain that LYBALVI does not affect them adversely.

Body Temperature Dysregulation: Use LYBALVI with caution in patients who may experience conditions that increase core body temperature (e.g., strenuous exercise, extreme heat, dehydration, or concomitant use with anticholinergics).

Anticholinergic (Antimuscarinic) Effects: Olanzapine, a component of LYBALVI, was associated with constipation, dry mouth, and tachycardia. Use LYBALVI with caution with other anticholinergic medications and in patients with urinary retention, prostatic hypertrophy, constipation, paralytic ileus or related conditions. In postmarketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications.

Hyperprolactinemia: LYBALVI elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds.

Risks Associated with Combination Treatment with Lithium or Valproate: If LYBALVI is administered with lithium or valproate, refer to the lithium or valproate Prescribing Information for a description of the risks for these products. 

Most common adverse reactions observed in clinical trials were: 

• Schizophrenia (LYBALVI): weight increased, somnolence, dry mouth, and headache
• Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor
• Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (olanzapine): dry mouth, dyspepsia, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia

Concomitant Medication: LYBALVI is contraindicated in patients who are using opioids or undergoing acute opioid withdrawal. Concomitant use of LYBALVI is not recommended with strong CYP3A4 inducers, levodopa and dopamine agonists. Reduce dosage of LYBALVI when using with strong CYP1A2 inhibitors. Increase dosage of LYBALVI with CYP1A2 inducers. Use caution with diazepam, alcohol, other CNS acting drugs, or in patients receiving anticholinergic (antimuscarinic) medications. Monitor blood pressure and reduce dosage of antihypertensive drug in accordance with its approved product labeling.

Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with LYBALVI. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LYBALVI during pregnancy.

Renal Impairment: LYBALVI is not recommended for patients with end-stage renal disease (eGFR of