Competitive Intelligence

P&G’s Intrinsa: Cautious FDA Says No Approval for Female Testosterone Patch

P&G’s new Intrinsa testosterone patch for women with low sexual desire just didn’t make the cut in the approvals process recently, leaving millions of under-sexed husbands, which one could suspect as the primary target market for the therapy, wondering when their monastic lives will ever end:

A more cautious Food and Drug Administration dealt Procter & Gamble a setback in its bid to be first to market a drug to improve women's sex drive.

An advisory committee of the FDA on Thursday recommended that P&G's female sex-drive drug Intrinsa needs more study before it's approved for U.S. consumers.

Studies indicate that women who take the drug, which is meant to restore sexual desire in women who have undergone hysterectomies during menopause, could face an increased risk of heart attack and stroke.

"It is not an acceptable tradeoff and we cannot allow this to move forward until we have more data," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic Foundation and a member of the panel.

Several members of the advisory committee said they were not satisfied with the number of women studied so far, the length of the studies and the modest benefits of the drug. The FDA usually follows the recommendations of its advisors.

Eyeing potential blockbuster sales, Cincinnati-based P&G had hoped to get the drug to U.S. women by next year. Company officials said after the panel's unanimous vote they would work with the FDA to determine what additional information was needed. They declined to say how long Intrinsa's launch could be delayed.

"That's purely speculative at this point," said spokesman Tom Millikin. He also declined to comment on whether P&G was concerned about losing its head start to any rival.

FDA appears to be more cautious about new drug approvals since the Vioxx debacle, where the popular pain medication stayed on the market despite evidence of possible lethal side effects.

"We're clearly in a different regulatory environment in light of recent events including the Vioxx withdrawal," Millikin said.

Sena Lund, an analyst with Cathay Financial in New York, said any changes to the approval process will impact all drug companies looking to launch new products.

"The FDA is under pressure right now internally and from the government," he said. "It's going to affect companies with drugs in the pipeline."

Still, he added pharmaceutical companies are accustomed to investing millions of dollars and several years to bring a drug to market, which is part of the reason why new medicines have such high profit margins.

Larry Hess, an analyst with Moody's Investors Service in New York, said P&G wouldn't want to risk its reputation by putting a drug on the market before it's ready but said the panel's decision must be discouraging. Since Intrinsa would have been the first female sex-drive drug on the market, it could have locked up a commanding share.

Pfizer was first to market with a drug addressing men's sexual impotence -- Viagra, now worth more than $1 billion in sales a year -- in the late 1990s. Industry experts have estimated that any drug for female sexual dysfunction could rack up similar sales.

"P&G views medical as a faster growing and more profitable area for the company," Hess said. "The returns are higher and the capital investment isn't as heavy."

Focus on Intrinsa comes as P&G's drug business has helped power its growth in recent years through its osteoporosis drug Actonel and non-prescription heartburn drug Prilosec OTC.

P&G sought to market the testosterone patch Intrinsa to women who lost their libido after their ovaries were removed.

Clinical trials showed that women using Intrinsa had modest sex- life improvements. Women who applied the patch to their abdomen twice weekly had one more "satisfying sexual event" per four weeks, according to the data presented to the panel.

Agency officials noted a lack of controlled safety data for women who had used Intrinsa longer than six months.

About 3 million women whose ovaries were removed would have been eligible to use the Intrinsa patch, according to the company. However, it was widely expected it would have been used off-label by women who wanted to increase their sex drive.

Critics said they were worried months or years of testosterone therapy may be dangerous. The hormones estrogen and progestin were prescribed to women for years following menopause before risks of heart disease and breast cancer came to light. P&G said its research showed Intrinsa, placed on the abdomen and changed twice a week, helped women who were distressed by a lack of sexual desire and produced no serious side effects during 24-week trials. The company has proposed studying Intrinsa's safety for five years after approval. That's an almost laughable approach strategy in the post-Vioxx pharma regulation environment.

P&G studied about 1,000 women who said they were bothered by low sex drive and, on average, reported three satisfying sexual experiences per month. The number increased to five for women who were treated with Intrinsa, but also rose to four for women given a dummy patch. "I don't want to expose several million American women to the risk of a heart attack or a stroke ... in order to have one more sexual experience per month. It is not an acceptable trade-off," said panel member Dr. Steven Nissen, a cardiologist from the Cleveland Clinic. P&G is aiming at a narrow group of about 2 million women who have undergone removal of their ovaries, the source of half the body's testosterone, are taking estrogen and are bothered by a lack of sexual desire. But several panel members were worried the patch would be used much more widely.

So really, what’d they expect after the Vioxx debacle and all the testimony from Dr. Graham about the FDA’s lax approach to drug approvals? Signs of things to come, me thinks… in a world of drug regulation that has been irrevocably altered.

- Arik