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Phase II Clinical Trial Initiated for Extended Release Formulation of Zaleplon
Jefferson J. Gregory, Chairman and Chief Executive Officer of King, stated, "We are pleased to announce the initial dosing of the first patients in the Phase II clinical trial program for the development of an extended release formulation of Sonata®." Mr. Gregory added, "With U.S. patent coverage that extends to 2018, the extended release formulation should establish Sonata® as a long-term cornerstone product for our Company. Moreover, this development program should provide us with the opportunity to procure additional patents potentially covering, among other things, unique biopharmaceutical characteristics and methods-of-use related to the extended release formulation of Sonata®."
The prescription insomnia market equaled approximately $2.0 billion in the U.S. during 2003 and is expected to grow to over $3.5 billion by 2008.
Michael K. Jolly, Pharm. D., Executive Vice President, Research and Development, of King, commented, "The goal of the Phase II clinical trial program is to determine which new formulation is the most efficacious for the purpose of increasing total sleep time and reducing any potential for premature awakenings, while continuing to build upon the quick onset profile currently available in the immediate release formulation of Sonata."
Sonata® is indicated for short-term insomnia treatment. Although Sonata® improved sleep time from baseline in clinical trials, it has not been shown to increase total time slept or decrease awakenings versus placebo. Hypnotics should generally be limited to 7-10 days use, and reevaluation of patients is recommended if hypnotics are taken more than 2-3 weeks. Sonata® prescriptions should not exceed a one-month supply. Until patients know how they will react to sleep agents, they should not engage in activities requiring mental alertness or motor coordination (e.g. driving or operating machinery) after taking Sonata® or any sleep agent. Psychomotor functions may be impaired for up to 4 hours. In clinical trials, the most common side effects were headache, dizziness, and somnolence. As with any sedative/hypnotic, abrupt treatment discontinuation can produce signs and symptoms of withdrawal and rebound insomnia.
Source: King Pharmaceuticals