Outpost Medicine announced the U.S. Food and Drug Administration (FDA) has accepted two Investigational New Drug (IND) applications for its lead product candidate, OP-687. The FDA Division of Bone, Reproductive and Urologic Products (DBRUP) and the Division of Gastroenterology and Inborn Errors Products (DGIEP) accepted the INDs for the treatment of overactive bladder (OAB) and irritable bowel syndrome (IBS), respectively.
"The acceptance of these INDs is an important milestone for the OP-687 program, allowing us to immediately initiate clinical testing," said Scott Byrd, Chief Executive Officer of Outpost. "We are excited about the possibilities for this first-in-class treatment for OAB and IBS and are now well positioned to rapidly advance the clinical program."
Overactive bladder is an urgent need to pass urine resulting from involuntary signals sent to the bladder muscles causing the bladder to contract before it is full. People with OAB may feel sudden and potentially strong urges to urinate, often accompanied by urinary incontinence (leakage). More than 10 percent of people worldwide are estimated to be affected by OAB.
Irritable bowel syndrome is a chronic gastrointestinal disorder affecting the large intestine, causing cramping, abdominal pain, bloating, gas, as well as diarrhea, constipation or both. Symptoms of IBS are believed to stem from abnormal functioning of gastrointestinal nerves and muscles and/or dysfunctional signaling between them. According to the American College of Gastroenterology, up to 15 percent of the global population may suffer from IBS.