Alkermes Completes Patient Enrollment in Phase 2 Study of ALKS 3831, a New Oral Antipsychotic

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Alkermes plc today announced completion of patient enrollment in a phase 2 study of ALKS 3831, an investigational, novel, oral, broad-spectrum atypical antipsychotic medicine in development for the treatment of schizophrenia. ALKS 3831 is composed of samidorphan, a novel, potent mu-opioid antagonist, in combination with the established antipsychotic drug, olanzapine. The double-blind, active-controlled, dose-ranging study will assess ALKS 3831’s efficacy, safety and tolerability in the treatment of schizophrenia and its attenuation of weight gain, compared with olanzapine. Weight gain is a common and clinically relevant metabolic side effect of atypical antipsychotic medications. Clinical studies have demonstrated that olanzapine has one of the highest incidences and greatest amounts of weight gain among widely prescribed atypical antipsychotics.1

“This clinical study of ALKS 3831 is designed to evaluate the efficacy of ALKS 3831 in the treatment of schizophrenia and its ability to attenuate olanzapine-associated weight gain. We are pleased to have now completed enrollment and look forward to reporting the results from this study early next year.”

This double-blind, olanzapine-controlled phase 2 study randomized 309 patients at multiple centers in the U.S. and Europe. Alkermes expects topline results from the 12-week, double-blind treatment period of this phase 2 study in early 2015. The double-blind treatment period will be followed by an additional 12-week period in which all patients will receive ALKS 3831.

“There is a clear and compelling clinical rationale for developing an antipsychotic with the efficacy of olanzapine and a safety profile that addresses the negative health impact of weight gain associated with olanzapine,” said Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “This clinical study of ALKS 3831 is designed to evaluate the efficacy of ALKS 3831 in the treatment of schizophrenia and its ability to attenuate olanzapine-associated weight gain. We are pleased to have now completed enrollment and look forward to reporting the results from this study early next year.”

More info: http://www.alkermes.com/

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I like Olanzapine except for it’s weight gain. If ALKS3821 can pass the phase 3 study, it would be a blessing for us.

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It was the first med my son was introduced to. It worked so well-it was like night and day. He stopped taking it because of the weight gain. I hope this works. I believe it is in an injectable form also,

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Wow this is very interesting. I took Zyprexa a while back but had to get off of it because I was gaining weight and my blood sugar levels were rising drastically. It did not work so well, but I really could not judge its efficacy because I was only on 5 mg, a very low dose. My doctor said that higher doses of Olanzapine might of worked for me - this new drug could be a winner, who knows

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green6,how long have you been on olanzapine already?i saw your photo before,you didn’t seems to gain much weight on it huh…

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I had been on Olanzapine for nearly one year back in 2007. It gave me about 15 kg in total so I had to buy new clothes for the added weight. I was skinny before around 45-50 kg though.

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now your not on olanzapine?i wonder did the meds let you gain weight,or did the medication cause you to eat a lot and then you start to gain weight?

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Olanzaping did increase my appetite, but I did not eat too much. In stead, I drank water. But I still gain some weight on this med. about 10-15 kg

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i put on 28 pounds on zyprexa. i didn’t mind though as i needed to put on weight. it was seroquel that added another 42 pounds. then i was desperately unhappy. so far i’ve lost 35 pounds of it. just another 21 pounds to go…never trusting large doses of seroquel again. zyprexa not as bad.