FDA approves Bayer Consumer Care's Ketoprofen prescription-to-OTC switch.

PARSIPPANY, N.J.--(HealthWire)--Oct. 9, 1995--The U.S. Food and Drug Administration (FDA) today cleared the Bayer Corp.'s Consumer Care Division's application to market a ketoprofen-based pain reliever, Actron(TM), as an over-the-counter analgesic.

Actron(TM) is indicated for the temporary relief of minor aches and pains associated with the common cold, headache, toothache, muscular aches, backache, minor pain of arthritis, menstrual cramps and for the temporary reduction of fever.

For more than 20 years, Bayer has marketed prescription formulations of ketoprofen in 27 countries around the world. Ketoprofen is currently available in the United States by prescription for the treatment of rheumatoid arthritis, osteoarthritis, dysmenorrhea (menstrual cramps) and management of pain. The prescription dosage range is from 75mg to 300mg daily.

With more than 5 billion doses of ketoprofen prescribed worldwide, including 900 million doses in the United States since 1986, there have been relatively few reported side effects. The most common side effects are comparable to those of other prescription NSAID analgesics.

Clinical studies involving more than 5,000 subjects demonstrated the safety and efficacy of ketoprofen. Studies also show that milligram for milligram, Actron(TM) is more powerful than acetaminophen or ibuprofen. Because ketoprofen offers such efficient pain relief, the recommended Actron(TM) dose is only 12.5mg -- which is as effective as 200mg of ibuprofen and 650mg of acetaminophen. Actron(TM) offers pain sufferers powerful medication with a short half-life -- which means it works fast to relieve tough pain and leaves the body fast.

Due to its small dose (12.5mg), Actron(TM) will feature an easy-to-swallow pill size. This, along with its potency and demonstrated efficacy, should provide the more than 150 million analgesics users in the United States with a new option in pain relief.

``Ketoprofen has enjoyed a long-standing reputation as an effective prescription medication,'' said Gary Balkema, president of the Bayer Consumer Care Division. ``We are looking forward to offering Actron(TM) to consumers as the newest member of the Bayer Consumer Care family of brands.''

``We are very pleased with the FDA's speed in approving ketoprofen for over-the-counter use,'' said Steven M. Weisman, Ph.D., director of Medical and Clinical Affairs at Bayer Consumer Care. ``Consumers who are dissatisfied with existing OTC pain relievers now have a new choice to help them find relief from minor aches and pains.''

Bayer Corp. (formerly Miles Inc.) manufactures and markets prescription and non-prescription drugs worldwide. It's Consumer Care Division, located in Parsippany, is the maker of a number of leading products including Bayer(R) Aspirin, Alka-Seltzer(R), Mycelex(R)-7, Midol(R) and One-A-Day(R) vitamins.

Bayer Corp., the U.S. subsidiary of the international chemical 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.

Product insert available upon request.

CONTACT: Golin/Harris Communications Inc., Chicago

Linda Z. Braden, 312/836-7382

Barbara Box, 312/836-7161