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Transdermal Patch Formulation Of Anti-Anxiety Medication Holds Promise For Treating Hyperactive Children

Duke University researchers report results at NIMH conference



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MIRAMAR, Fla., June 6, 1997 -- Administration through a skin patch developed by Sano Corporation (Nasdaq: SANO) of a widely used anti-anxiety medication may provide a safe and effective treatment alternative for children with attention deficit hyperactivity disorder (ADHD) -- the nation's most common pediatric mental disorder -- according to the results of a pilot study presented at a National Institute of Mental Health conference.

The drug buspirone (BuSpar(R), Bristol-Myers Squibb) was administered to a group of 32 children with ADHD using a new transdermal (through the skin) delivery technology. The transdermal buspirone patch is not yet commercially available and will require completion of current trials as well as the necessary FDA review and approvals.

Following the eight-week, open-label study, 70-80% of patients treated were rated by parents and teachers as "much improved or very much improved," according to study-leader C. Keith Conners, Ph.D., Professor of Medical Psychology at Duke University Medical Center. "The treatment was well liked by parents and well tolerated by the patients in the study - important considerations in evaluating prospective therapies for ADHD," said Dr. Conners.

He noted that the results of transdermal buspirone evaluated in the phase II trial suggest that the therapy may offer several benefits for treatment of ADHD in children.

  • Unlike oral medications that must be taken repeatedly at home and school, the transdermal patch is applied once each morning, relieving children and their caregivers of the daily responsibility and stigma of pill-taking.

  • Oral medications are frequently metabolized in the liver. In the drugs currently used to treat hyperactivity and attention deficit disorder this so-called "first-pass metabolism" releases active drug components erratically, creating fluctuations which increase the risk of inconsistent control of symptoms.

"The main difference is that oral drugs' side effects are associated with their peak level in the bloodstream, which is higher than their therapeutic level," Dr. Conners noted. "If you can reduce these peak levels, you can avoid a lot of adverse effects." He said that this may help account for the tolerability of the transdermal buspirone noted in the study.

The study looked at boys and girls aged 8-12 years who were physically healthy and had been diagnosed with ADHD. Two eight-child groups wore low- dose skin patches measuring either 2.5 cm2 or 5 cm2. Two high-dose groups of eight children began the treatment period with skin patches measuring 10 cm2 or 20 cm2. Patches were replaced daily. The high-dose skin patches were increased in size every 10 days.

According to Dr. Conners, the study demonstrated a relationship between dose and effect. That is, the two high-dose groups showed improvement in terms of clinical global impairment ratings by parents and teachers, while the low-dose groups showed less improvement. He characterized the side effect profile as mild and well tolerated.

The adverse effects reported were mild or moderate in severity and included insomnia (15.6%), reaction at the site of the patch (12.5%), headache (9.4%), and increased activity level (9.4%). There was one severe headache. The next steps in evaluating the therapy will be the analysis of placebo- controlled efficacy studies currently underway. The studies are being conducted by Sano Corporation's partner Bristol-Myers Squibb which holds world-wide exclusive marketing rights to the product. If the current clinical trials are successful the product will then be submitted for approval by the FDA.

Between 2 and 3.5 million children suffer from ADHD, the principal characteristics of which are inattentiveness, impulsiveness and hyperactivity. Children with ADHD are often perceived as disobedient, noncompliant and defiant, which may adversely affect their relationships with parents, teachers and other authority figures. ADHD symptoms typically inhibit a child's ability to perform in school and thrive in social situations; as a result, patients frequently suffer emotional problems, such as depression and anxiety, according to Dr. Conners.

Current drug therapy for ADHD includes oral, multi-dose stimulants such as methylphenidate, dextramphetamine and pemoline, thought to stimulate dopamine secretion and thus increase impulse control; and antidepressants, which decrease hyperactivity and aggressive behavior. A number of behavioral interventions are also commonly implemented.

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 applied 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 10Q 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.

CONTACT: Marcia A. Kean/Rob Gould, Feinstein Kean Partners Inc., 617-577-8110; or Reginald L. Hardy, President, Sano Corp., 954-430-3340

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