FDA Agrees to Priority Review for Sucampo Constipation Drug

Andrew Klips |

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.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

Companies

Symbol Name Price Change % Volume
MS.P.I Morgan Stanley Depository Shares Representing 1/10 27.87 -0.18 -0.64 57,103
SCMP Sucampo Pharmaceuticals Inc. 12.30 -0.63 -4.87 258,716

Comments

Emerging Growth

CohBar Inc.

CohBar Inc is a research stage biotechnology company. The Company conducts investigational research into Mitochondrial-Derived Peptides to evaluate their therapeutic potential through in vitro and in vivo models.

Private Markets

Cloudera

Cloudera offers enterprises a new data platform built on the Apache Hadoop open-source software package. Hadoop is a data-management platform that can consolidate data in a single repository for comprehensive…

Ozobot by Evollve Inc

Ozobot is a world leader in compact super intelligent robots that entertain and educate through fun interactive gaming.