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Discovery Therapeutics Starts Pivotal Phase II Trial of Anti-Parkinson's Skin Patch Source: Business Wire RICHMOND, Va.--(BUSINESS WIRE) via Individual Inc. -- Discovery Therapeutics, Inc. has started a pivotal Phase II study of its transdermally-delivered dopamine D2 receptor agonist, N-0923, to be administered as a skin patch in patients with Parkinson's disease (PD). The double-blind, placebo-controlled study will enroll up to 75 patients with moderate to severe PD at six to eight centers in the United States and Canada. "This study was prompted by encouraging results in a Phase IIa study conducted earlier this year by Dr. Vincent P. Calabrese at the Medical College of Virginia," said Donald A. McAfee, president and CEO of Discovery Therapeutics. "In a group on nine Parkinson's patients, the N-0923 TDS (transdermal delivery system) ameliorated symptoms for up to 30 hours, the length of time that patients wore the patches." N-0923, the only dopamine agonist that has been demonstrated in human clinical trials to be efficacious when delivered through the skin using a transdermal patch, is being developed as an adjunct treatment to levodopa/carbidopa therapy. Because transdermal administration provides stable and continuous plasma levels of medication, the N-0923 TDS should help improve the fluctuations and sudden loss of symptom control that many PD patients experience. Stable levels of N-0923 should reduce the need for supplemental doses of levodopa/carbidopa and therefore help patients avoid side effects, such as dyskinesia (jerky or irregular movement). Study patients will wear the patches during waking hours (approximately 14 hours/day) for 21 days. The study will begin and end with short hospital stays; patients will apply and remove their own patches at home during the interim period. They will report to study sites each week for assessments and will complete home diaries recording symptom control and any dosages of levodopa/carbidopa taken. Trial endpoints include reduction in daily levodopa/carbidopa dose and improvements in symptom control. Five U.S. study centers will begin dosing patients in November, with three additional sites expected in early 1997. An interim analysis will be conducted when 25 patients have completed dosing for 14 days to determine early trends. Discovery Therapeutics expects to complete the trial in the first quarter of 1997. More than $1 billion (U.S.) are spent worldwide for therapeutic agents to treat PD, a debilitating neurological disorder that afflicts more than 1 percent of the U.S. and European population over the age of 50. Patients experience rigidity, difficulty in walking, muscle tremor and slowness of movement. The disease is caused by degeneration of a specific region in the brain that secretes dopamine, a neurotransmitter signal molecule used to coordinate voluntary muscle activity, and most treatments therefore consist of various attempts to supplement the action of dopamine. The N-0923 patch may be especially helpful for the approximately 50 percent of PD patients who experience difficulty swallowing and are now forced to take their medication by grinding up their tablets and mixing them with soft foods. Not only is this inconvenient, but erratic absorption of orally administered anti-parkinsonian drugs may contribute to poor symptom control. Transdermal administration would also be helpful for patients who undergo surgery and cannot take oral medications, sometimes for periods of up to several days. Discovery Therapeutics Inc. is an independent company founded to invent, develop and commercialize pharmaceuticals for poorly met medical needs using novel signal molecule technology. Discovery Therapeutics has two technology platforms: one based on dopamine for the treatment of movement disorders and the other on adenosine for the treatment and diagnosis of coronary artery disease and cardiac dysrhythmias. CONTACT: Discovery Therapeutics | Dr. Donald A. McAfee, 804/358-9468 | or | EMM Communications | Ellen M. Martin, 510/832-7604 [11-14-96 at 09:20 EST, Business Wire]