Allergan’s depression drug awarded FDA Breakthrough Therapy status
pharmafile | January 29, 2016 | News story | Research and Development, Sales and Marketing | Allergan, depression, rapastinel
While still adjusting to life as part of Pfizer, Allergan has received some good news in the form of the company’s first ever Breakthrough Therapy designation from the FDA- for its depression drug Rapastinel. The new designation follows the Fast Track designation granted by the US regulator in 2014.
In America, some 16 million people suffer from Major Depressive Disorder (MDD) and there remains a significant unmet need in treatments, as up to 70% of patients do not or only partially respond to first-line therapies, including SSRIs and SNRIs.
Rapastinel showed a rapid onset of antidepressant efficacy one day after a single dose in a Phase II clinical trial of patients with MDD who had an inadequate response to one or more antidepressants. This is significant, as there is currently a lack of depression drugs with rapid onset. Also encouraging was that no psychotomimetic or hallucinogenic side effects were observed with Allergan’s drug. Based on the results to-date, the company intends to begin a series of Phase III registration trials in 2016.
“Breakthrough Therapy designation will allow us to work more closely with the FDA to bring this important therapy to patients as rapidly as possible,” says David Nicholson, executive vice president and president of Global R&D brands at Allergan. “There remains an unmet medical need for agents in depression that demonstrate a rapid onset of action. We believe that rapastinel has great potential to fulfill that unmet medical need in major depressive disorder.”
Joel Levy
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