Development of Postpartum Depression Drug Expedited
Sage Therapeutics plans to work with the FDA to expedite the approval of a drug for postpartum depression.
Sage Therapeutics recently announced they are expediting the development of SAGE-547, which could treat postpartum depression.
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors intended to treat women experiencing postpartum depression after giving birth. The clinical-stage biopharmaceutical company decided to expedite the drug’s development after they met with the FDA in a breakthrough therapy meeting, according to a press release from Sage.
The current development program for SAGE-547 in patients with postpartum depression, along with phase 2 clinical trial data, are supporting the submission for a New Drug Application.
Sage reported that accelerating the phase 3 development of the drug will only require slight modifications, such as increasing the number of patients included in the trials. The company and the FDA collaborated to determine the clinical endpoints for these clinical trials, according to the press release.
Top-line results are expected to be announced in the second half of 2017. Sage recently announced positive results from the 202A placebo-controlled trial in women with severe postpartum depression. In this trial, patients who were taking SAGE-547 experienced a rapid, long-lasting reduction in depression scores compared with those taking placebo.
According to the press release, the FDA outlined several important elements that need to be followed in order to expedite the clinical and regulatory path towards approval. Agreement and clarity has already been achieved with the FDA regarding the next steps in development, and current clinical trials are able to support registration.
There are no additional efficacy studies needed besides the ongoing trials, and patient safety data should be received through an open-label program. The designs of the 202B and 202C clinical trials are appropriate for registration with increased size and minor changes, and the endpoints of these studies were agreed upon with the FDA, Sage reported.
SAGE-547 originally received Breakthrough Therapy Designation for postpartum depression this year. With the Breakthrough Therapy title, the drug is able to be expedited through development for review from the FDA. It also requires extra guidance and input from the FDA.
The drug was granted Breakthrough Therapy Designation due to positive results from the clinical trial 202A, which included 21 patients with severe postpartum depression, according to the press release. The results showed a significant reduction in depression score compared with placebo at 60 hours, and lasted for the 30-day follow-up period.
The drug was generally well-tolerated with no serious adverse events experienced.
Currently, there are no approved treatments for postpartum depression, which affects up to 750,000 women per year. Untreated postpartum depression can lead to functional impairment, depressed mood, loss of interest in her newborn, or even suicide. Some patients even require hospitalization due to the severity of their condition.
If SAGE-547 received FDA approval, it may mean that hundreds of thousands of women can receive effective treatment.
"We are encouraged by the FDA's feedback and appreciate their guidance regarding our SAGE-547 development program in postpartum depression," said Jeff Jonas, MD, chief executive officer of Sage. "Based on our meeting, we have clear and efficient direction for the expedited development path forward for SAGE-547 to potentially support a New Drug Application in 2018."