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| |  ACR: Pennsaid Topical Lotion Provides Site-Specific Pain Relief For OA Patients BOSTON, MA and TORONTO, ON -- November 15, 1999 -- Dimethaid Research Inc. announced that results of a Phase III multi-center study of Pennsaid® (diclofenac) Topical Lotion were presented at the 63rd Annual Scientific Meeting of the American College of Rheumatology (ACR). Pennsaid Topical Lotion has been developed for the treatment of osteoarthritic (OA) pain.
"This conference provides Dimethaid with an important opportunity to present this compelling data to researchers and clinicians. The data was included in our regulatory submission in the United Kingdom and resulted in a recommendation for marketing approval from the Committee on Safety in Medicines, further validating our product's ability to work effectively and safely," stated Dr. J. Zev Shainhouse, Medical Director of Dimethaid. The clinical results demonstrate significant site-specific pain relief from Pennsaid Topical Lotion with only minor local irritation and no systemic toxicity. "My lifetime of work in the arthritis field has made me acutely aware of the dangers of oral NSAIDs," said Dr. Sanford H. Roth, founder and past president of the American Society of Clinical Rheumatology and the International Society for Rheumatic Therapy. "The safety advantage of a topical NSAID is widely recognized. The efficacy data on this new topical diclofenac lotion is the most convincing I have seen to date for any topical OA product and will provide an alternative to oral medications which are often accompanied by negative side effects." The double-blind, placebo-controlled trial of Pennsaid was conducted with patients suffering from osteoarthritis of the knee. The primary outcome measure was the pain subscale of the WOMAC OA Index and secondary outcome measures were the subscales for stiffness and physical function, as well as a patient global assessment. Statistical analysis demonstrated that Pennsaid provided significant benefit as compared with both a control (the carrier alone) and with a placebo for the primary and all secondary outcome measurements (p less than 0.05). Dimethaid Research has developed a proprietary transdermal delivery system that facilitates the delivery of drugs to the site of disease with minimal systemic absorption. Pennsaid Topical Lotion is the first product developed by the Company that incorporates this unique carrier technology. Dimethaid International Inc., a wholly owned subsidiary, and McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, have entered into a standstill agreement for US distribution rights to Pennsaid. Dimethaid International is also negotiating distribution rights for Pennsaid in other geographical areas.
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