mid controversy and fanfare, regulators last year approved a pill called Addyi, which became the first medicine for combating female sexual dysfunction.
The endorsement came despite lingering questions about safety and effectiveness, but also followed a high-stakes pressure campaign in which the manufacturer accused the Food and Drug Administration of gender bias, since several pills were already approved for men with sexual problems.
Although some had great expectations for the drug, Addyi has, so far, been a bust. Not only have sales been meager, but the pill and its manufacturer — Valeant Pharmaceuticals — rate poorly on several measures that should be of concern to women and doctors, according to an advocacy group that on Thursday released a report card for the drug’s one-year anniversary.
Why bother issuing a report card for a pill that has not rung registers? As part of its deal last year to buy Sprout Pharmaceuticals and the Addyi drug, Valeant committed to spend $200 million on sales and other expenses through June 2017 (see page 13). And even though the company voluntarily agreed last summer to refrain from consumer advertising for 18 months, this means that women could start seeing ads early next year.
“This is a risky drug about which women and their doctors don’t get enough information,” said Cindy Pearson, who heads the National Women’s Health Network, which released the report card. “It’s true that not many women are using the drug now, but once advertising starts, we can expect more women to see the messaging and become interested in the product. And that means more women are likely to be exposed to the risks.”
In fact, the company was given a “D” for provider education.
The FDA required Valeant to develop a risk management program, which involves distributing materials about usage and side effects to doctors. But the advocacy group contends the effort is skimpy and Valeant should include more information about complications from interactions with alcohol and other drugs.
“They should beef it up,” said Pearson. “They don’t give prescribers any guidance for having a conversation about alcohol avoidance.” This is an important issue, because combining Addyi and alcohol has been shown to exacerbate the drug’s side effects, including low blood pressure, dizziness, and fainting. A Valeant spokeswoman said the company “stands by” its program.
To be fair, the report card also gave Valeant a “D” for issues that are already well-known, such as contraindications and practicality.
Valeant, however, received an incomplete grade for three follow-up studies required to explore the interaction between the drug and alcohol. The first trial was supposed to have been completed this month, but the FDA website lists it as pending, which means the study has not been initiated (type in “flibanserin” in the product box here).
The company is also required to conduct two pregnancy-outcome-related studies and submit a final protocol last March before starting the studies shortly afterward. “We’re giving Valeant an incomplete on this subject because there’s no way for women to be confident that these studies will be done in a timely way if the company hasn’t even started the first, much simpler, study,” said Pearson.
The Valeant spokeswoman wrote us that the first alcohol interaction study actually began enrolling patients and argued the drug maker is not responsible if that information is not reflected on the FDA website. And she maintained that the protocols for the pregnancy registry and maternal-fetal outcomes studies are under review at the FDA. An FDA spokeswoman told us the website is updated quarterly but declined to provide more information because it’s considered proprietary.
The company, meanwhile, received an F for affordability. Addyi costs about $800 for a month’s prescription. Women with private insurance can use a coupon provided by Valeant to cover a $50-a-month copay. The coupon is good for seven months, Pearson explained. For uninsured women and those covered by government programs, the company provides a coupon that expires after three months to purchase the drug for $125 a month. “They’re too limited,” Pearson said.
The company spokeswoman responded: “Valeant is in the process of completing all of our post-marketing commitments to the FDA on Addyi, as scheduled. We are committed to making Addyi accessible to women who need it and are actively working with health insurers and pharmacy benefit managers to secure the optimum level of access possible.”