GlaxoSmithKline, Adolor fill trial studying Entereg for gastrointestinal pain of opioids ahead of target

By Elaine Rigoli

Tampa, Fla., April 13 - GlaxoSmithKline and Adolor Corp. announced Thursday that GlaxoSmithKline has completed enrollment of the phase 3 clinical program to evaluate the efficacy and safety of the oral investigational drug Entereg (alvimopan) for the treatment of gastrointestinal adverse events caused by opioids used for persistent non-cancer pain.

The phase 3 international, multi-center program includes two efficacy-safety studies (SB-767905/012 and SB-767905/013) and one long-term safety study (SB-767905/014), according to a news release.

Enrollment was completed earlier than anticipated and the companies are targeting the submission of New Drug Application and marketing authorization application filings in mid-2007, the release said.

"Our ability to enroll these studies faster than expected, we believe, may indicate large unmet need in this patient population. This will help us advance the development of Entereg for the millions of patients using opioids for persistent pain," said Yvonne Greenstreet, GlaxoSmithKline senior vice president, medicine development center, in a statement.

Enrollment has also ended for a phase 2b study evaluating Entereg in cancer pain patients taking chronic opioid therapy, the release said.

Opioids are highly effective in the treatment of pain and are widely used to treat persistent pain such as pain associated with, or as a result of, back pain, arthritis and other pain conditions.

However, the use of opioids is associated with medium- to longer-term side effects such as constipation, abdominal pain and discomfort, bloating, gastro-oesophageal reflux and loss of appetite, the release said.

Adolor is an Exton, Pa.-based biopharmaceutical company specializing in the discovery, development and commercialization of prescription pain-management products.

GlaxoSmithKline is a London-based pharmaceutical and health care company.

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