Contact: Eveline Honig, MD, 914-741-5680, 914-319-9743 cell, ehonig@narcolepsynetwork.org

NORTH KINGSTOWN, R.I., July 2 /Standard Newswire/ -- The Narcolepsy Network today released the following statement.

Just days before the manufacturer of the narcolepsy medication Xyrem made an initial public offering of its shares, the New York Times and two affiliates published an article that was both unnecessarily negative and blatantly misleading in its portrayal of Xyrem, a first-line treatment for narcolepsy. Narcolepsy patients expressed outrage over such negatively biased and unbalanced reporting, especially as it threatens to railroad the efforts of Narcolepsy Network and its members to educate the public about narcolepsy and its treatments and could jeopardize future availability of this important medication.

The issues involve inaccurate and misleading information presented in the article "Maker of Risky Narcolepsy Drug to Sell Shares", by Alex Berenson, a Market Place column published in the May 31, 2007 late edition of the New York Times. (An abridged version, titled "Maker of Risky Narcolepsy Drug Plans IPO", was published in two affiliated newspapers as well.)

Medicinal Use vs. Abuse

There is a world of difference between the legitimate use of a medicinal substance and illegal recreational abuse. Throughout his article, Mr. Berenson draws from GHB's track record of abuse in describing Xyrem as "risky", "as dangerous as heroin or LSD" and as having "a history of use in date rape and serious risks of overdose, including coma and death." In fact, these eventualities are extremely unlikely in the case of prescription Xyrem, given the extensive physician/prescriber and patient education mandated by the FDA as a condition of Xyrem's approval and strictly adhered to prior to the actual dispensing of this medication to a patient. Mr. Berenson has seemingly included irrelevant information for its shock value and in a manner that is highly misleading to his readership. Sharon Smith, President of Narcolepsy Network's Board of Trustees and a narcolepsy sufferer herself explains, "Narcolepsy patients prescribed Xyrem have a completely different mindset than the recreational GHB abuser. Narcolepsy patients have great respect for Xyrem. The safety precautions are a necessary but minor inconvenience and well worth what it takes to achieve such relief from the overwhelming sleepiness and cataplexy that otherwise plague our waking hours."

Other Inaccuracies

Categorization of Xyrem GHB is described as "a fast-acting" anesthetic. While GHB has a history of use as an anesthetic aid in Europe, it has never been used as such in the U.S. Xyrem is not an anesthetic; it is a sedative prescribed to persons with narcolepsy and in this respect, has a similar action to other popular prescription sleep aids such as Ambien, Lunesta, Sonata, et al. The primary benefit of Xyrem over other sleep aids is that only Xyrem improves the sleep quality of persons with narcolepsy.

Risk of Overdose

The article claims there are serious risks of overdose. This is totally inconsistent with actual patient experience. From the earliest studies of GHB's efficacy in the treatment of narcolepsy symptoms through clinical drug trials and post-approval patient experience, there have been no cases of coma or death reported in patients taking Xyrem as directed. Coma and/or death have only occurred in individuals knowingly or unknowingly combining GHB with alcohol or other multiple drugs of unknown propensity.

FDA scheduling

The article states that "the Drug Enforcement Administration lists GHB as a Schedule I drug" while "the FDA has approved Xyrem for narcolepsy", as if therein lies some fundamental problem with these differing treatments. In actuality, the same federal legislation -- Pub. L. 106-172 -- which criminalized the manufacture and trafficking of GHB in 2000 recognized that there was at least one legitimate medicinal use for this substance and therefore included an exception from Schedule I for formulations containing gamma hydroxybutyric acid approved by the FDA as investigational new drugs. This legislation also provided for bifurcated scheduling upon approval of any such formulation such that scheduling would be determined in the ordinary course, without respect to this new legislation.

Schedule I drugs are not released for use in the United States; they are generally deemed to be dangerous with no legitimate medical use and/or with risks that outweigh any potential benefits. When the FDA approved Xyrem in 2002, it classified Xyrem a Schedule III drug. A restricted delivery system was mandated to reduce the risks that this medication could be diverted for illicit use. The Schedule III classification is consistent with drugs that carry some risk of abuse but are known to be relatively safe and well tolerated when taken as prescribed. Hydrocodone and Codeine are also Schedule III drugs.

Omissions

Mr. Berenson correctly describes narcolepsy as a "serious sleep disorder." Without adequate treatment narcolepsy is very often disabling. He did not mention that the active ingredient in Xyrem mimics a substance that occurs naturally in the brain; that Xyrem is a first-line treatment for narcolepsy; that it is the only approved medication that treats all major symptoms of this disorder, and that, while no one medication works for every patient, the vast majority of Xyrem patients tell us "Xyrem has given me my life back!" Mali Einen talks about her narcolepsy before and with Xyrem. "For a time, I was prescribed off-label medications to treat my sleepiness and cataplexy. Their lack of effectiveness cost me a highly rewarding career in finance. When side effects led me to discontinue those medications, my sleepiness and cataplexy were so severe I wasn't able to leave my house. Ten years ago, a Xyrem clinical trial turned my life around. Thanks to Xyrem, I've been able to return to work full-time and I can experience a full range of emotions without collapsing with cataplexy."

The incidence of narcolepsy is estimated to be between 120,000 to 200,000 persons in the U.S. It's further estimated that less than half of this patient population has been diagnosed, and only 25 percent of diagnosed patients are currently taking Xyrem. While Xyrem was approved in 2002 for the treatment of cataplexy, its more recent approval in late 2005 for use in treating excessive daytime sleepiness associated with narcolepsy likely has not yet been fully applied at the patient level. Meanwhile, patients who began taking GHB in the earliest studies have now been taking Xyrem and its predecessor for over 20 years and are showing no long-term adverse side effects. Leading narcolepsy expert, Dr. Emmanuel Mignot, Director of Stanford University's Center for Narcolepsy, states. "In my experience, sodium oxybate can be a safe, miracle drug for treating people with narcolepsy".

About Narcolepsy

Narcolepsy is an often disabling disorder of the sleep-wake cycle. Symptom onset typically begins around puberty with excessive daytime sleepiness but symptoms can present in any order and begin earlier or later in life. Symptoms usually progress over a period of years, often negatively impacting educational and career goals. Symptoms include bouts of overwhelming excessive daytime sleepiness and sleep attacks; cataplexy (a sudden loss of voluntary muscle control triggered by strong emotion such as elation, surprise, fear and anger that can result in total body collapse; often terrifying hallucinations at sleep onset and/or upon awakening; sleep paralysis (the inability to move upon waking or while falling asleep) and disrupted nighttime sleep that reduces sleep quality, thereby contributing to daytime sleepiness.

The exact cause of narcolepsy is not known, but patients whose symptoms include cataplexy have been found to be lacking two neurotransmitters called hypocretins that are critical to the proper regulation of sleep and wakefulness. In addition, 97 percent of narcolepsy patients share a specific autoimmune marker, making it highly likely that there is an autoimmune process involved in the development of narcolepsy. Further research is needed to more fully understand the disease process of narcolepsy.

Narcolepsy Network Inc. is a national nonprofit patient support organization founded in 1986 and dedicated to the needs of the narcolepsy community. We educate, assist and provide emotional support to patients and others impacted by narcolepsy; further public awareness of narcolepsy; promote early diagnosis and treatment and research into the causes of and treatments for narcolepsy, and advocate in all areas for the rights of persons with narcolepsy.

For additional information on narcolepsy, please contact Joyce in our national office at 401-667-2523.