FDA approves Bayer Consumer Care's ACTRON Rx-to-OTC Switch.

PARSIPPANY, N.J.--(HealthCare)--Oct. 10, 1995--The U.S. Food and Drug Administration (FDA) today approved Bayer Corp.'s ACTRON(TM) (ketoprofen) for over-the-counter (OTC) marketing by the company's Consumer Care Division.

The non-sterodial anti-inflammatory drug (NSAID) is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, the minor pain of arthritis, menstrual cramps (dysmenorrhea), and for the temporary reduction of fever.

The FDA issued its approval announcement after reviewing clinical trial data involving about 10,000 patients, including more than 5,000 treated with ketoprofen. The agency concluded that the 12.5-milligram (mg) dose of ACTRON is safe and effective for OTC use, and that the drug's rapid absorption and short half-life make ketoprofen suitable for OTC indications.

"This is important news for the 150 million users of analgesics in the United States," said Gary S. Balkema, president of the Bayer Consumer Care Division. "The availability of an OTC form of ketoprofen will provide consumers with a new choice for fast effective pain relief."

Ketoprofen, a propionic acid derivative, has been available in the United States by prescription since 1986 for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea and management of pain. The prescription dosage range in the United States is from 75mg to 300 mg daily. More than 900 million doses have been dispensed in the United States since 1986, and more than 5 billion doses have been prescribed worldwide. Bayer has marketed prescription formulations of ketoprofen in 27 countries around the world for more than 20 years.

A series of randomized, double-blind, placebo-controlled clinical trials have demonstrated the safety and efficacy of ACTRON(TM). Four of these studies focused on dental pain as a model for general pain, three studies involved patients with dysmenorrhea and two studies were conducted in fever.

In these studies the analgesic and antipyretic efficacy of ketoprofen was noted as soon as 30 minutes after dosing and lasted up to six hours. The overall incidence of adverse events was low, with dyspepsia, or stomach upset, the most commonly cited adverse effect. In these studies ACTRON did not differ from comparative treatments in terms of adverse effects.

In addition, a prospective, single-blind, randomized multicenter study involving more than 6,000 patients was conducted to document consumer use patterns and to identify potential safety issues. In this study, the safety, efficacy and usage pattern of ketoprofen 12.5mg was found to be similar to ibuprofen 200mg when used for the OTC indications by the consumer population. In patients treated with ketoprofen, gastrointestinal adverse events were the most commonly reported adverse events, but were infrequent (no individual event greater than 2%) and not serious.

"Clinical trials have shown that the safety profile of this product is similar to other OTC analgesics, and the safety margin has been further extended by the use of the 12.5mg dose," said Steven M. Weisman, Ph.D., director of Medical and Clinical Affairs at Bayer Consumer Care.

"It is well known that choice is important to patients who have variable responses to different NSAIDs," Dr. Weisman noted. "The rapid attainment of maximum plasma concentration and the short half-life make ketoprofen well suited for OTC availability. In addition, the small size (7.0mm diameter) of the ACTRON tablet may offer an additional convenience, particularly for those patients who find larger tablets difficult to swallow."

The Bayer Consumer Care Division, located in Parsippany, N.J. is a division of Bayer Corp. (formerly Miles Inc.); which manufactures and markets prescription and non-prescription drugs worldwide. Products include Bayer(R) Aspirin, Alka-Seltzer(R), Mycelex(R)-7 and One-A-Day(R) vitamins.

Bayer Corp., the U.S. subsidiary of the international chemicals and health care company, Bayer AG, Germany, is a research-based company with major businesses in health care, chemicals and imaging technologies. Headquartered in Pittsburgh, Bayer Corp. employs 24,000 people and had sales of $7.1 billion in 1994.

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