Alkermes PLC (NASDAQ: ALKS) shares made a handy gain on Monday after the firm announced that it would be expanding its New Drug Application (NDA) for ALKS 3831 to encompass the treatment of bipolar I disorder in addition to the treatment of schizophrenia.
Following a pre-NDA meeting with the U.S. Food and Drug Administration (FDA), the company plans to make this expansion.
The ALKS 3831 NDA, which the company now plans to submit in the fourth quarter of 2019, will include data from the completed ALKS 3831 Enlighten clinical development program in patients with schizophrenia as well as pharmacokinetic bridging data comparing ALKS 3831 and Zyprexa (olanzapine).
The ALKS 3831 NDA will include data to support an indication for the treatment of manic or mixed episodes associated with bipolar I disorder as a monotherapy, or adjunct to lithium or valproate, and for maintenance treatment of bipolar I disorder and an indication for the treatment of schizophrenia.
Roger S. McIntyre, M.D., Professor of Psychiatry and Pharmacology at the University of Toronto, head of the Mood Disorders Psychopharmacology Unit at the University Health Network in Toronto and director for the Depression and Bipolar Support Alliance (DBSA), commented:
Bipolar I disorder is a complicated and often misdiagnosed disease, characterized by severe shifts in mood and energy that can impact a person’s ability to complete day-to-day activities. Antipsychotics are a mainstay treatment option for many people living with bipolar I disorder; however, new treatments with differentiated efficacy and tolerability profiles are needed. A potential new medication like ALKS 3831 would be a meaningful addition to the bipolar I disorder treatment landscape.
Shares of Alkermes were last seen up about 4% at $23.39, in a 52-week range of $21.29 to $46.98. The consensus price target is $33.67. Note that shares were up as much as 10% in early trading indications.