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Classified in: Health, Science and technology
Subject: FDA

Outpost Medicine Announces Acceptance of Two Investigational New Drug Applications for OP-687 by U.S. FDA


INDIANAPOLIS and LONDON, Jan. 17, 2018 /PRNewswire/ -- Outpost Medicine, a biopharmaceutical company focused on the development of new treatments of urologic and gastrointestinal disorders, today announced that 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.

Outpost Medicine Logo (PRNewsfoto/Outpost Medicine)

"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."

"Current treatments for OAB and IBS have significant limitations in terms of both efficacy and tolerability, resulting in high rates of treatment failure," commented Dr. Ian Mills, Chief Medical Officer. "We believe OP-687 has the potential to meaningfully improve care for millions of patients suffering from these serious disorders."

About Overactive Bladder
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.

About Irritable Bowel Syndrome
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.

About Outpost Medicine
Outpost Medicine is a biopharmaceutical company focused on the development of novel therapeutics for the treatment of urologic and gastrointestinal disorders. Located in Indianapolis and London, Outpost is a private company launched in 2016 and has raised $64 million in Series A venture capital financing from Frazier Healthcare Partners, Adams Street Partners, Novo Holdings A/S, Vivo Capital and Takeda Ventures. For more information, visit Outpost's website at www.outpostmedicine.com.

Contact:
Theresa Owens
Targeted Communications
[email protected]
+1-317-983-4476

 

SOURCE Outpost Medicine


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