The U.S. Food and Drug Administration has granted priority review status to drug developer Sucampo Phamaceuticals Inc. (SCMP) and partner Takeda Pharmaceutical Co. for the drug Amitiza as a treatment of opioid-induced constipation in patients with chronic, noncancer pain.
The regulatory agency had previously approved Amitiza for the treatment of chronic idiopathic constipation in adults and for irritable bowel syndrome with constipation in adult women.
The FDA designation is given to expedite the review process for drugs that treat conditions that have little to no therapeutic options or drugs that represent a significant advancement over current treatments. Priority reviews will generally shave about four months of the process that normally takes ten months.
Sucampo and Takeda are expecting the FDA to make a decision on approval by late January 2013. Shares of SCMP have traded in a range of $3.37 to $8.50 in the last 52 weeks and closed trading Tuesday at $4.53.