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Lilly menstrual drug OK'd
July 6, 2000: 5:24 p.m. ET

FDA clears Sarafem, first prescription drug for menstrual mood symptoms
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NEW YORK (CNNfn) - The federal government has approved the first prescription drug for women suffering from the temporary depression and severe physical symptoms of premenstrual syndrome.

Actually, it's an old drug with a new name.

Eli Lilly and Co.'s Sarafem is really a form of Prozac, which at more than 34.5 million prescriptions is the most widely prescribed antidepressant of its kind.


But with a regulatory nod Thursday from the U.S. Food and Drug Administration, it became the first prescription drug that may be marketed specifically for treating premenstrual dysphoric disorder, or PMDD.

Lilly brought in $2.16 billion in sales of Prozac last year, the company said.

"Lilly's primary goal is to help provide relief for the millions of American women who suffer from this disorder," said Gary Tollefson, president of neuroscience products for Indianapolis-based Lilly.

Doctors have been prescribing other drugs such as Zoloft and Celexa, to treat PMDD for several years.

But Lilly, which posted $10 billion in sales last year, now has the right to market a drug to treat PMDD, which affects 3-to-5 percent of menstruating women in the United States and is characterized by severe mood and physical symptoms.

Although a breakthrough for Lilly, some analysts do not see the FDA's approval of Sarafem significantly boosting Lilly's earnings or revenue.

graphic"It's Prozac. They've essentially given it another name," said Mario Corso, an analyst with ABN Amro Inc. "They may have lowered the dosage for this ... but I don't expect it to be a meaningful product for them."

In clinical studies, women treated with Sarafem, which contains fluoxetine hydrochloride, the same active ingredient found in Prozac, experienced statistically significant improvement in mood and physical symptoms, Lilly said. In addition, women taking the drug also improved in social functioning compared with women taking a placebo.

Sufferers who would be candidates for the drug experience such severe symptoms that it interferes with every day activities or relationships.

The drug will come with educational materials about PMDD and will be packaged in a box of four 7-day blister packs. It will be available by August, Lilly said.

Scientists don't know the exact way fluoxetine works in the treatment of PMDD, but experts believe normal cyclical changes in female hormones may interact with neurotransmitters, including seratonin, that may result in the mood and physical symptoms of PMDD.

Dr. Stephen Leviss, a gynecologist who chairs the pharmacy and therapeutics committee at Morristown Memorial Hospital in Morristown, N.J., said doctors have known for a long time that Prozac and related drugs, a class called selective seratonin uptake inhibitors, are effective for treating severe pre-menstrual symptoms.

"It's marketing ... once a drug is approved by the FDA, doctors can use it for anything ... This gives them a jump on the market. How much they keep of it depends on the prescribing habits of doctors."

Leviss, who said he gets two or three queries a day from patients about PMDD treatment, said he didn't think he was likely to prescribe Sarafem until more is learned about its effectiveness and possible side effects.

Shares of Eli-Lilly (LLY: Research, Estimates) closed down 2-7/8 to 101-5/8 Thursday, after the announcement. Back to top