Monday, January 28, 2013

Surprise Over Oxytrol Approval

In a press release last week, Kalorama Information said that there would be more Rx to OTC switches, and to count on it.... but we had no idea how quickly that would happen.  Last Friday, the FDA announced that Oxytrol was approved by the FDA for OTC status this year.   Merck's OXYTROL is a prescription medication that has been proven to treat the symptoms of overactive bladder.   The product is expected to be released end of year.  

The FDA advisory panel in November recommended not allowing the drug to switch yet, so Kalorama did not include the product in it's Rx to OTC Switches report.  

"Everyone is a bit surprised," analyst Melissa Elder tells the Kalorama Editors. "especially in light of no restrictions mentioned--such as pharmacist-dispensing option--and the concern over men gaining access to the product without the monitoring of a pharmacist. "

According to Elder, it raises some concerns over the possibility of men not being evaluated for prostate problems--and as we all know many men will avoid a Dr. visit if at all possible. 

Kalorama had forecasted 2014 approval in its report so our forecast is not affected in any large scale by the faster than expected approval, especially as Merck should not see revenues until fall 2013.