Merck & Co. (MRK), the third-largest U.S. drugmaker by revenue, may not have shown that women can safely use the company’s overactive-bladder medication Oxytrol without a doctor prescription, U.S. regulators said.
Food and Drug Administration staff asked advisers to vote on whether Merck’s data supports that women can appropriately use the patch in an over-the-counter setting. The FDA staff released its report today ahead of a Nov. 9 advisory panel meeting to discuss the drug, which Merck is seeking to make the first bladder treatment available without a prescription.
Merck bought the rights to nonprescription Oxytrol from Watson Pharmaceuticals Inc. (WPI) The FDA is scheduled to decide on Merck’s Oxytrol by the end of January, said Edwin Hemwall, associate vice president of clinical research for prescription to over-the-counter switches at the Whitehouse Station, New Jersey-based company. The patch is suited for nonprescription use because of less frequent side effects than oral overactive- bladder drugs, he said.
“It’s a category that affects 20 million women in the U.S.,” Hemwall said in a telephone interview before the report was released. “Up to 80 percent self-manage the condition already without seeking help from a health-care professional.”
Self-management includes purchasing pantyliners or pads to manage leaks and not leaving the house for long periods of time. Side effects of overactive bladder medications are dry mouth, constipation and abnormal vision.
40 Million Patches
The agency approved Oxybutrol in 2003 and 40 million patches have been distributed worldwide through February 2011, according to the report.
“In accordance with FDA regulations, if a drug can be OTC, it should be OTC,” FDA staff wrote.
Some consumers failed to correctly decide whether they could take the drug based on their understanding of the label and their symptoms and as well as other conditions that might indicate they shouldn’t take Oxytrol, the FDA staff said. Some men also incorrectly chose to take the product labeled specifically for women.
FDA staff didn’t find any new safety signals for use of over-the-counter Oxytrol, according to the report.
The FDA hasn’t convened an advisory panel for a switch to nonprescription status in five years, Hemwall said.
The agency said earlier this year it’s considering expanding the list of drugs that can be bought without a doctor’s order to lower costs and ease access to drugs for people with chronic ailments. The FDA held a meeting on the proposal in March focusing on cholesterol, asthma, migraine and blood-pressure medications that could benefit from new technologies such as kiosks to help people determine whether a drug is appropriate for them.
Merck began its program studying Oxytrol five years ago, Hemwall said.
“We’re very pleased to see how FDA has started thinking about innovation in switch,” he said.
Merck doesn’t anticipate it will need the new technology to help make the Oxytrol switch, he said.
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