Data presented at the 175th Annual Meeting of the American Psychiatric Association (APA) support the potential of the investigational drug ALKS 3831 to provide the antipsychotic efficacy of olanzapine without the associated weight gain, said Adam Simmons, director of clinical program management, Alkermes. He also discussed the timing of when the data might be filed with the FDA.
Data presented at the 175th Annual Meeting of the American Psychiatric Association (APA) support the potential of the investigational drug ALKS 3831 to provide the antipsychotic efficacy of olanzapine without the associated weight gain, said Adam Simmons, director of clinical program management, Alkermes. He also discussed the timing of when the data might be filed with the FDA.
Transcript
How do the data presented at APA support the value of ALKS 3831?
Through the data that we’re presenting here at APA, we’re demonstrating the 2 things that we wanted to demonstrate with this product: that the efficacy that you see when combining samidorphan and olanzapine is similar to that known efficacy of olanzapine, and then the data that we’ll be sharing here as well, that’s going to be presented by Dr Correll tomorrow, is our ENLIGHTEN-2 data, where we’ve demonstrated clinically significant reductions in weight gain with the combination product versus olanzapine alone.
What’s the timetable for a filing with the FDA?
We’re currently putting together the data, the combined package of which we’re sharing here at APA, and we’re expecting on filing that data with the FDA later this year.
The Importance of Examining and Preventing Atrial Fibrillation
August 29th 2023At this year’s American Society for Preventive Cardiology Congress on CVD Prevention, Emelia J. Benjamin, MD, ScM, delivered the Honorary Fellow Award Lecture, “The Imperative to Focus on the Prevention of Atrial Fibrillation,” as the recipient of this year’s Honorary Fellow of the American Society for Preventive Cardiology award.
Listen
Promoting Equity in Public Health: Policy, Investment, and Community Engagement Solutions
June 28th 2022On this episode of Managed Care Cast, we speak with Georges C. Benjamin, MD, executive director of the American Public Health Association, on the core takeaways of his keynote session at AHIP 2022 on public health policy and other solutions to promote equitable health and well-being.
Listen
Specialty Pharmacists at the Forefront: Elevating Care for Rare Diseases
May 1st 2024In the US, a disease is considered rare when it affects fewer than 200,000 persons, or 1 in every 1500 individuals, with an estimated total of 25 to 30 million Americans overall living with a rare disease at any given time.
Read More
Latest Advances and Updates of Treatment in the Real World at AUA
May 1st 2024The annual meeting of the American Urological Association (AUA) not only presents the newest therapies coming out but showcases the latest in how treatments are being used in the real world, said Stephen Freedland, MD, of Cedars Sinai.
Read More