According to Corstasis Therapeutics, the FDA has approved the company’s NDA for Enbumyst (RSQ-777) bumetanide nasal spray for the treatment of edema associated with heart, kidney, and liver disease. In January 2025, Corstasis announced that the FDA had accepted the NDA for review with a PDUFA goal date of September 14, 2025. The company says that it anticipates launching Enbumyst in the US by the end of this year.
Corstasis CEO Ben Esque commented, “The FDA approval of Enbumyst represents a meaningful advancement in the treatment of edema for patients and providers.”
The company also recently announced former Abiomed Director of Medical Affairs Amin M. Medjamia as the company’s new VP of Medical Affairs. According to the announcement, Medjamia has more than 20 years experience, including multiple senior roles at Johnson & Johnson subsidiary Abiomed, which makes heart pumps.
Esque said, “We are honored to welcome Dr. Medjamia to Corstasis at this critical time. His passion and expertise in cardiovascular medicine and evidence strategy will strengthen our ability to develop and deliver new pathways to improve patient outcomes and reduce cost of care.”
Read the Corstasis Therapeutics press release on the FDA approval
Read the Corstasis Therapeutics press release on the Medjamia appointment
