Psych Congress and NEI Congress 2024: Alkermes highlights key data on psychiatric treatments and narcolepsy research

Alkermes announced the presentation of research related to Lybalvi (olanzapine and samidorphan) and Aristada (aripiprazole lauroxil), the company’s commercial products in psychiatry, and ALKS 2680, an investigational medicine in development as a once-daily treatment for narcolepsy and idiopathic hypersomnia, at two scientific conferences this fall. The two meetings—the 37^th Annual Psych Congress (Psych Congress), which took place Oct. 29-Nov. 2, 2024 in Boston, and the 2024 Neuroscience Education Institute (NEI) Congress, taking place Nov. 7-10, 2024 in Colorado Springs, Colorado—represent important opportunities for Alkermes to showcase the breadth and depth of its work in neuroscience.

“The wealth of data being presented at these important medical gatherings underscores the substantive research being conducted at Alkermes to understand the experiences of people taking our commercial and investigational medicines, as well as advance knowledge about the complex disease states in which we work,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. “We are excited to share our insights with stakeholders from across the psychiatric and neuroscience communities and engage in valuable scientific exchange to help advance care for patients living with schizophrenia, bipolar I disorder and narcolepsy.”

Among the posters, Alkermes presented results from a real-world, retrospective study of healthcare resource utilization (HCRU) and treatment patterns in patients with schizophrenia and patients with bipolar I disorder in the 12 months following initiation of LYBALVI. To be included in the study, patients must have had at least one medical or pharmacy claim for LYBALVI, with the date of such claim serving as the date of treatment initiation. The analysis included claims for 1,287 patients with schizophrenia and 1,004 patients with bipolar I disorder enrolled in commercial, Medicare or Medicaid plans and was designed to assess and compare HCRU in the 12 months before and after initiation of LYBALVI.

Among patients with schizophrenia, the research showed statistically significant reductions (p<0.001) in all cause, mental health-related, and disease-related inpatient admissions (25%, 27%, and 24% relative reductions, respectively) and emergency department (ED) visits (13%, 27%, and 22% relative reductions, respectively) following initiation on LYBALVI compared to the 12-month period before LYBALVI initiation. Similar results were observed in patients with bipolar I disorder, with statistically significant reductions (p<0.001) in all cause, mental health-related, and disease-related inpatient admissions (34%, 39%, and 42% relative reductions, respectively) and ED visits (16%, 32%, and 29% relative reductions, respectively). Change in the number of outpatient visits, inpatient days and length of inpatient stay was also evaluated. Additional analyses were performed in the subset of patients who stayed on LYBALVI for the entire 12-month period, which included 37% of patients with schizophrenia and 30% of patients with bipolar I disorder.

Limitations of the study included those inherent to administrative claims, including that the insured population studied may not be representative of uninsured populations; claims do not capture disease severity and are subject to data omissions or coding errors; the HCRU reported may not fully capture the effects of longer term LYBALVI use; and a claim for a filled prescription does not indicate medication adherence.

In addition, Alkermes presented multiple posters related to the company’s work in narcolepsy, including:

• Safety and efficacy data from the proof-of-concept phase 1b study of ALKS 2680, the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist, in patients with narcolepsy type 1 and narcolepsy type 2; and
• Research from in-depth, qualitative interviews and systematic literature reviews designed to better understand the clinical, economic and humanistic burden associated with narcolepsy.

The full list of Alkermes’ presentations by meeting is as follows:

Psych Congress

• Poster #23: Safety and Pharmacodynamic Effects of the Orexin 2 Receptor Agonist ALKS 2680 in Patients With Narcolepsy Type 1: A First-in-Human Phase 1 Study
• Poster #125: The Burden of Living With Narcolepsy: Patient Perspectives From In-Depth Qualitative Interviews
• Poster #126: Clinical, Economic, and Humanistic Burden Associated With Narcolepsy: Results From a Systematic Literature Review
• Poster #170: The Orexin 2 Receptor Agonist ALKS 2680 in Patients With Narcolepsy Type 2: An Initial Proof of Concept Phase 1b Study
• Poster #40: Long-Term Safety and Efficacy of Olanzapine/Samidorphan: Results of a 4-Year Open-Label Study
• Poster #62: Healthcare Resource Utilization 12 Months Following Initiation of Olanzapine/Samidorphan: Real-World Assessment of Patients With Bipolar I Disorder
• Poster #63: Healthcare Resource Utilization 12 Months Following Initiation of Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia
• Poster #118: Study Retention Rates in the OLZ/SAM Phase III Clinical Program
• Poster #119: Treatment Effects of Olanzapine/Samidorphan on Negative Symptoms in Patients With Schizophrenia: A Post Hoc Analysis
• Poster #69: Baseline Severity of Illness and Response to Treatment With Aripiprazole Lauroxil Every 2 Months: A Post Hoc Analysis of Phase 3 ALPINE Clinical Trial Data
• Poster #70: Treatment Patterns and Healthcare Resource Utilization of Patients With Schizophrenia Prescribed Aripiprazole Lauroxil Versus Oral Aripiprazole: A Retrospective Claims-Based Study
• Poster #100: Treatment Patterns and Healthcare Resource Utilization Following Initiation of Aripiprazole Lauroxil Using a 1-Day Initiation Regimen

NEI Congress

• Poster 73: The Burden of Living With Narcolepsy: Patient Perspectives from In-Depth Qualitative Interviews
• Poster 74: Clinical, Economic, and Humanistic Burden Associated With Narcolepsy: Results From a Systematic Literature Review
• Poster 23: Long-Term Safety and Efficacy of Olanzapine/Samidorphan: Results of a 4-Year Open-Label Study
• Poster 39: Healthcare Resource Utilization 12 Months Following Initiation of Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia
• Poster 40: Healthcare Resource Utilization 12 Months Following Initiation of Olanzapine/Samidorphan: Real-World Assessment of Patients With Bipolar I Disorder
• Poster 42: Baseline Severity of Illness and Response to Treatment With Aripiprazole Lauroxil Every 2 Months: A Post Hoc Analysis of Phase 3 ALPINE Clinical Trial Data
• Poster 61: Treatment Patterns and Healthcare Resource Utilization Following Initiation of Aripiprazole Lauroxil Using a 1-Day Initiation Regimen
• Poster 62: Treatment Patterns and Healthcare Resource Utilization of Patients With Schizophrenia Prescribed Aripiprazole Lauroxil Versus Oral Aripiprazole: A Retrospective Claims-Based Study