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| |  Phase III Program On Trandermal Buspirone Patch Initiated MIRAMAR, Fla., Feb. 18, 1997 -- Sano Corporation (Nasdaq: SANO) today announced that its partner, Bristol-Myers Squibb, has initiated an extensive Phase III clinical trial program on Sano's transdermal buspirone patch. The program includes multiple trials for the treatment of both anxiety and attention deficit hyperactivity disorder (ADHD). The trials, which will be conducted by Bristol-Myers Squibb, encompass multiple centers in the United States and Europe. "Sano's transdermal buspirone has advanced to this important milestone following evaluation of data from our preclinical and clinical program, including the first two recently completed Phase III studies of the product," said Reginald Hardy, president of Sano. "We are very pleased with the clinical program initiated by Bristol-Myers Squibb, as well as the rapid review of the recent data. Sano is producing over 1.5 million patches in support of this program." In the United States there are over 10 million people troubled by persistent anxiety. Persistent anxiety involves excessive, unfounded worry that lasts for more than six months, as well as other physical and mental symptoms such as irritability, muscle tension, restlessness, fatigue and sleep disturbance. In 1996 sales of anti-anxiety drugs worldwide reached over $2 billion. Sano's transdermal buspirone will provide a new, convenient, once-daily dosing form of this proven drug. A portion of this clinical program involves Phase III trials of the buspirone patch for the treatment of attention deficit hyperactivity disorder, which is sometimes referred to as attention deficit disorder (ADD), in children. ADHD consists of developmental deficiencies in the regulation and maintenance of behavior and occurs most frequently in children. These deficiencies give rise to inattention, impulsivity and hyperactivity. Sano's transdermal buspirone patch offers the convenience of a once-a day dosing of a non-controlled substance. Worldwide sales of the current treatment for ADHD exceeded $350 million in 1996. Sano Corporation develops novel controlled release drug delivery systems for drug therapies licensed from others and for off-patent drugs. Sano's transdermal delivery systems use a patch that incorporates the drug dosage into an adhesive that attaches the patch to the skin. The Company has filed with the FDA for approval of three generic transdermal products, and has a number of other proprietary and generic products in various stages of development. This press release contains forward-looking statements regarding future events and the future performance of Sano that involve risks and uncertainties that could cause actual results to differ materially including, but not limited to, timely development, FDA approval, and the commencement of sales. We refer you to the documents that Sano files from time to time with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q and Form 8-K reports, which contain additional important factors that could cause our actual results to differ from our current expectations and the forward-looking statements contained in this press release.
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