For Wyeth, Another Day, Another Setback - Or Two
Make a commentBy Ed Silverman // March 12th, 2008 // 9:32 am
First, the drugmaker withdrew its application in Europe to have Pristiq approved to treat menopausal hot flashes. Then, Wyeth and Progenics Pharmaceuticals say their intravenous bowel drug failed in late-stage trial to improve gastrointestinal functioning after surgery.
This continues a string of disappointments and delays that have frustrated Wyeth execs, who have taken to blaming regulators for the lack of approvals. The only good news the drugmaker has received about its late-stage pipeline came last month, when the FDA approved Pristiq for treating depression.
Europe’s Committee for Medicinal Products for Human Use raised safety questions that will require new trials. Wyeth is initiating a 12-month study, but may consider more.
“We believe that desvenlafaxine can provide women with a non-hormonal option to treat vasomotor symptoms, and Wyeth remains committed to developing the molecule for this indication,” Gary Stiles, Wyeth’s chief medical officer, says in a statement.
Meanwhile, preliminary results from a Phase III trial showed the bowel drug didn’t achieve its main goal in reducing recovery time for gastrointestinal function - which is measured by time to first bowel movement- as compared with a placebo. Results from another late-stage trial are expected to be reported by midyear. Both trials are measuring the management of postoperative ileus (POI), a dysfunction of the GI tract following surgery.
“Despite the results of this phase 3 trial for POI, we remain confident in the methylnaltrexone development program,” Robert Ruffolo, Wyeth’s R&D chief, says in a statement. Earlier this year, the FDA delayed approval of a subcutaneous form of the drug for constipation associated with the use of opioid pain drugs, and Wyeth hopes the FDA will give it blessing by the end of April.