Schizophrenia drug ALKS 3831 completes Patient enrollment in a pivotal study


Alkermes plc (Nasdaq: ALKS) announced completion of patient enrollment in ENLIGHTEN-2, the second of two key phase 3 studies in the ENLIGHTEN clinical development program for ALKS 3831, an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of schizophrenia. The multicenter, randomized, double-blind phase 3 study will evaluate the weight gain profile of ALKS 3831 compared to olanzapine, an established atypical antipsychotic agent with proven efficacy but also metabolic liabilities, in patients with stable schizophrenia over a six-month treatment period. Topline results are expected in the fourth quarter of 2018.

“Designed to harness the well-established antipsychotic efficacy of olanzapine while mitigating its significant weight and metabolic liabilities, ALKS 3831 represents a promising potential new treatment option for patients suffering from schizophrenia,” said Craig Hopkinson, M.D., Chief Medical Officer and Senior Vice President of Medicines Development and Medical Affairs at Alkermes. “ENLIGHTEN-2 is designed to confirm and build upon the favorable weight profile observed in the previously reported randomized, olanzapine-controlled 300-patient phase 2 study. Completion of patient enrollment in the ENLIGHTEN-2 weight study marks a significant milestone in the development of this important potential new medicine, and we look forward to reporting results later this year.”

Clinical data from ENLIGHTEN-2, if successful, and positive data from the previously reported ENLIGHTEN-1 study will form the basis of a New Drug Application (NDA) that we plan to submit to the U.S. Food and Drug Administration (FDA) for ALKS 3831 for the treatment of schizophrenia.

Positive topline data from ENLIGHTEN-1, the first key phase 3 study from the ENLIGHTEN development program, were reported in June 2017. This study evaluated the antipsychotic efficacy, safety and tolerability of ALKS 3831 compared to placebo over four weeks in 403 patients experiencing an acute exacerbation of schizophrenia. ENLIGHTEN-1 met its prespecified primary endpoint, with ALKS 3831 demonstrating statistically significant reductions from baseline in Positive and Negative Syndrome Scale (PANSS) scores compared to placebo (p<0.001). Data from the study also showed that the olanzapine comparator arm achieved similar improvements from baseline PANSS scores compared to placebo (p=0.004). The most common adverse events for both the ALKS 3831 and olanzapine treatment groups were weight gain, somnolence and dry mouth.


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News Source: Alkermes Website

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