Progenics, Wyeth constipation drug gets FDA approval

Federal regulators have approved the first drug meant to relieve constipation caused by narcotic painkillers, the drug's makers said Friday.

The Food and Drug Administration approval of Relistor , made by drugmaker Wyeth and partner Progenics Pharmaceuticals Inc. , could provide relief for a common problem for patients dying of cancer and other painful diseases.Wyeth expects to make Relistor available in the U.S. in June, spokesman Doug Petkus said.

Relistor was approved specifically for patients with advanced illnesses who are receiving opiates such as morphine to lessen their pain , and are suffering from constipation that laxatives aren't relieving sufficiently.

"Side effects associated with opioids, such as constipation, can be severe enough to limit pain management," Dr. Jay Thomas of San Diego Hospice and the Institute of Palliative Medicine, who participated in testing of the drug, said in a statement.

Petkus said up to 1.8 million Americans who receive pain treatment each year for an advanced illness, such as AIDS, incurable cancer or end-stage heart and lung disease, suffer from sometimes-debilitating constipation from opiate use. About 230 million prescriptions were written for opiates in the United States last year, he said.

Opiates relieve pain by interacting with receptors in the brain and spinal cord, but they also interact with receptors elsewhere in the body, such as in the gastrointestinal tract, which can cause constipation. Relistor blocks opiates from interacting with receptors outside the central nervous system, decreasing their constipating effects but not lessening pain relief.

The FDA approval for Relistor is the third in just nine weeks for Madison, N.J.-based Wyeth, but the first ever for Progenics, of Tarrytown, N.Y.

The two companies in December 2005 agreed to develop and market the drug, also known as methylnaltrexone. The marketing approval triggers a $15 million milestone payment to Progenics from Wyeth.

Progenics shares shot up 26 percent, or $2.76, to $13.40, while Wyeth shares increased 41 cents, to $44.97.

Friedman, Billings, Ramsey analyst David Amsellem wrote in a note to investors Friday that patients with advanced illnesses are the smallest market of three possible uses for which the companies have been testing the drug. Studies for the other two uses , chronic constipation and bowel obstruction after surgery , have run into problems.
Amsellem estimated peak worldwide sales of about $250 million for use in patients with advanced illness, while Cowen and Company analyst Steve Scalia forecast sales reaching $210 million a year in 2012.

The drug previously was approved for sale in Canada, on April 1.
Wyeth won approval for its antidepressant Pristiq, the drug maker's planned successor to its blockbuster Effexor, on Feb. 29. It got FDA approval on Feb. 1 for Xyntha, a genetically engineered clotting medicine to prevent and control bleeding in people with hemophilia. That snapped a streak in which the FDA four straight times either rejected a Wyeth experimental drug, demanded more data or required an entire new study.

Source : www.phillyburbs.com