Glaxo, Adolor suspend drug development over safety

Glaxo, Adolor suspend drug development over safety
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First Published: Tue, Apr 10 2007. 04 37 AM IST
Updated: Tue, Apr 10 2007. 04 37 AM IST
By Robert Greene and Luke Timmerman/Bloomberg
Washington/San Francisco: GlaxoSmithKline Plc and Adolor Corp. stopped a study of a bowel disorder drug after patients had more fractures, skin growths and heart attacks, sending Adolor’s shares down by 59%.
The companies are studying the drug alvimopan to help patients whose bowels aren’t properly functioning because they’re taking opioids for pain, they said in a statement on 9 April. The most common problem experienced by study participants on alvimopan was gastrointestinal distress including abdominal pain and diarrhea.
The companies stopped a study of 805 patients being treated for chronic non-cancer pain, the third of three trials usually required for regulatory approval in the US Glaxo and Adolar also withdrew the protocol for an additional advanced study of safety and efficacy in patients, they said in the statement.
“That will be of most concern to investors,” said Greg Wade, an analyst with Pacific Growth Equities in San Francisco. Wade owns Adolor shares, and his firm has done banking with the company.
Adolor, which has never had a quarterly profit since its founding, named a new chief executive officer and disbanded its 35-person sales force in December. The Exton, Pennsylvania-based company said it was eliminating the sales force because of delays in bringing alvimopan, also known as Entereg, to market.
Shares of Adolor plunged $5.18 to $3.54 after hours, from $8.72 at the close of regular Nasdaq Stock Market composite trading.
The US Food and Drug Administration in November asked for more data on the drug, including an analysis of “serious” cardiovascular side effects found in a study, the companies said in a statement on 6 November.
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First Published: Tue, Apr 10 2007. 04 37 AM IST