Long-term treatment with these REM suppressing compounds may be limited by efficacy, tolerance and adverse side effects such as dry mouth, weight gain, tachycardia and loss of libido. Cataplexy is poorly treated by current therapies and Xyrem represents a potential effective long- term treatment for this chronic disease. We plan to submit an NDA for Xyrem to the FDA later this year, and expect that it will be granted a priority review. If the FDA approves Xyrem, it will be an important new drug for the treatment of narcolepsy. This bill gives law enforcement officials the tools they need to punish those who use GHB illicitly and to commit crimes, while protecting patient access to a promising new drug.
Much more attention needs to be directed toward the development of drugs for rare disorders.
This bill recognizes the valid medical use of a drug for a seriously ill population of patients that have been neglected by medicine until now. I'm aware of many patients enrolled in Orphan Medical's clinical trials who, prior to receiving Xyrem, could not function on a daily basis, and now, with Xyrem, can hold jobs, drive, and perform functions that most of us take for granted. Orphan Medical, Inc. is dedicated to patients with inadequately treated and uncommon diseases. To that end, the acquires, develops, and markets products of high medical value for patients within selected strategic therapeutic market segments. The information in this press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.