Schering-Plough announces OTC release of MiraLax

Schering-Plough has announced the over-the-counter (OTC) release of its prescription-strength laxative MiraLax (polyethylene glycol 3350) as a treatment for occasional constipation.

The company reports that the drug is the first laxative to make the switch from prescription to OTC in the past 30 years, while trials showed that 70 per cent of patients preferred MiraLax to their usual treatment for constipation.

MiraLax, previously the market-leading prescribed laxative, is marketed by Schering-Plough through the firm’s exclusive licensing collaboration with Braintree Laboratories.

Jack A DiPalma, director of the division of gastroenterology at the University of South Alabama College of Medicine, said: “Laxatives that work gently with the body are preferred because people can live their lives normally.”

He added that while alternative medications can cause uncomfortable cramps, MiraLax does not and can allow patients to recover control of their body.

Schering-Plough first announced its licensing agreement with Braintree Laboratories to market MiraLax as an OTC medication in December 2006, following approval for the switch from the US Food and Drug Administration two months earlier.

Additionally, the drug will have three years of marketing exclusivity prior to the release of any generic OTC formulations of the compound.