Menlo Therapeutics’ Serlopitant Granted Breakthrough Therapy Designation by FDA

Menlo Therapeutics (NASDAQ:MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant for the treatment of pruritus (itch), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for serlopitant for the treatment of pruritus associated with prurigo nodularis (PN).

As quoted in the press release:

Breakthrough Therapy designation is granted to expedite the development and review process for drugs intended to treat a serious condition where preliminary clinical evidence indicates that the drug candidate may demonstrate substantial improvement over available therapies on a clinically significant endpoint.

“We are pleased that the FDA has granted Breakthrough Therapy designation for serlopitant for the treatment of pruritus associated with PN.  This designation is based upon data from our successful Phase 2 clinical trial in pruritus associated with PN and reflects the significant unmet need for treatment in this indication,” said Steve Basta, Chief Executive Officer of Menlo Therapeutics (Menlo).  “Our two ongoing Phase 3 clinical trials in pruritus associated with PN, one being conducted in the U.S. and the other in Europe, are enrolling well, and we look forward to working with the regulatory authorities with the goal of bringing this potential new treatment option to patients with prurigo nodularis.”

Click here to read the full press release.