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Adam Simmons: ENLIGHTEN-2 Data Demonstrate Efficacy, Reduced Weight Gain With ALKS 3831
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.
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