Schering-Plough Corporation has entered into an exclusive licensing agreement with Braintree Laboratories, Inc. to market MiraLAX (polyethylene glycol 3350), currently available by prescription, as a nonprescription treatment for occasional constipation.
Prior to generic competition in 2004, MiraLAX was the number one prescribed prescription laxative and is the first laxative to be approved by the US Food and Drug Administration (FDA) as a prescription to over the counter switch in over 30 years.
The FDA approved the prescription to OTC switch of MiraLAX on October 6, 2006. The FDA also ruled that MiraLAX would have marketing exclusivity for three years before any generic OTC versions of the product can be marketed.
"The Rx to OTC switch of MiraLAX offers millions of sufferers an innovative new, alternative for relief of constipation, which until now has been available only by prescription," said Jack A. DiPalma, M.D., immediate past president of the American College of Gastroenterology. As a prescription product, MiraLAX offered break-through treatment of constipation. When used as directed, it now provides this proven efficacy without a prescription, effectively treating constipation with no harsh side effects."
"We are pleased to have the opportunity to launch MiraLAX as an over the counter product," said Stan Barshay, chairman of Schering-Plough Consumer HealthCare Products. "Schering-Plough is an industry leader in switching products from prescription to non-prescription status."
The division's portfolio of switched products includes Coricidin, Afrin, Tinactin, Lotrimin, Drixoral and most recently, the switch of Claritin 24-hour, non-drowsy allergy products, which has surpassed the $1.5 billion mark in cumulative US OTC sales since launch.
MiraLAX is the first Rx-to-OTC switch in the laxative category in over 30 years. As the latest innovation in the OTC laxative category, MiraLAX will pioneer a new class of over-the-counter laxatives known as hyperosmotics. Unlike stimulant laxatives, MiraLAX works with your body's natural rhythm in a unique, four-way mode of action. The benefit of this unique mode of action is that it results in effective, predictable relief of constipation without harsh side effects. MiraLAX will be available nationally, shipping to drug stores, grocery stores, and mass merchandisers beginning in February 2007.
Schering-Plough Consumer Health Care is the US over the counter (OTC) and consumer products business unit of Schering-Plough Corporation a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 32,000 people around the world. The company is based in Kenilworth, New Jersey.