There are a number of times in a small drug company's development that it faces crucial tests.
Exton-based Adolor Corp. confronts one this week when it goes before a panel of advisors to the Food and Drug Administration over its compound to treat constipation after bowel surgery. That panel will vote Wednesday on whether Entereg should be approved.
Entereg would be Adolor's first drug, and it has been working on it with GlaxoSmithKline, which bought the rights to co-develop and market Entereg for as much as $270 million in 2002.
Shares of Adolor rose 22 cents, or 5.5 percent, to $4.25 Friday on news that FDA reviewers found the drug to be effective. There are currently no drugs approved for this condition. However, the 103-page briefing document also indicates the FDA has questions about the safety of Entereg, including serious heart problems.
As recently as April, financial analysts were raising questions as to whether Entereg would ever be commercially approved. Adolor's shares plunged 59 percent on April 10 after it suspended development of Entereg for a different indication: bowel discomfort associated with the use of opioid painkillers. The reason? Researchers documented a higher risk of heart attacks, tumors and bone fractures in patients who took the drug.
Analysts say the market for opioid-induced bowel dysfunction is much bigger than for postoperative ileus — the indication for which Adolor is currently seeking FDA approval.
The odds appear long for Adolor's success. Bloomberg News said the FDA's approval of 19 "novel" drugs in 2007 was the lowest number since 1983. Safety concerns have sunk many new drug applications, especially since the withdrawal of Merck & Co. Inc.'s Vioxx in 2004.
By the end of Wednesday, Adolor and its employees will know if they crossed another hurdle, or if the race is over.
