Update on Emend (MK-869)

[Adam Boyd]

It looks like Emend (MK-869) the first in an new class of medications, the NK-1 receptor antagonists, will most likely hit pharmacies in the US by this summer. Although this drug specifically has not been studied for CPPS, this class of drugs is widely recognized as a potential treatment for a variety of visceral pain syndromes. A similar drug, TAK-637, is currently in phase II trials for Irritable Bowel Syndrome and Urinary Incontinence. Likewise, Dr. Theoharides at Tufts University has suggested in a published report that NK-1 antagonists may be useful in the treatment of IC. If you're interested in reading more, check out medline. There are several published pre-clinical studies on this class of drugs.

From Reuters:

FDA Memo Supports Merck Anti-Vomiting Drug
Wed March 5, 2003 02:00 PM ET
By Ransdell Pierson
NEW YORK (Reuters) - Merck and Co. Inc.'s experimental drug to prevent vomiting caused by chemotherapy was better than standard therapy in clinical trials, according to a memo by a U.S. Food and Drug Administration official.

The memo, dated Feb. 6, said the FDA agreed the drug, Emend, in clinical trials achieved its primary objectives of significantly reducing vomiting among cancer patients who had received chemotherapy and of sparing them the need to take additional medicines to control vomiting.

The memo, posted on the FDA's Web site on Wednesday, was prepared by an official of the agency's Division of Gastrointestinal and Coagulation Drug Products.

When evaluated just for nausea, the official found the data on Emend was not persuasive, saying its superiority to several standard drugs was statistically significant in one trial, but not in another.

Even so, Merck spokesman Chris Loder said Emend was significantly better against nausea than the other drugs when data from the two trials were combined.

Although the primary goal of the trials did not evaluate nausea, Merck has asked the FDA to approve the drug for prevention of nausea and vomiting associated with chemotherapy.

"Our data provides a compelling case to support" the drug's marketing application, Loder said.

In one clinical trial, 73 percent of patients taking a combination of Emend and two standard treatments responded favorably, compared with 52 percent receiving the standard anti-vomiting treatments alone. The other drugs were GlaxoSmithKline Plc's Zofran and a corticosteroid called dexamethasone. Similarly favorable results for the Merck drug were observed in a second trial, the FDA memo said.

An FDA advisory panel will review Emend at a meeting on Thursday to make recommendations to the full agency on whether to approve the medicine. The FDA usually follows the recommendations of its advisory panels.

Some analysts expect Emend to have annual sales of roughly $400 million in 2006. That would make it a medium-sized drug for Merck, which has annual pharmaceutical sales of about $25 billion, but badly needs new drugs to replace medicines that have lost patent protection in recent years.

The Merck drug is the first in a new class of treatments for vomiting and nausea caused by chemotherapy, a condition known as emesis.

Merck shares were up 64 cents to $51.88 in afternoon trade on the New York Stock Exchange. (Additional reporting by Bill Berkrot and Jed Seltzer)