November 17, 2015
By Alex Keown, BioSpace.com Breaking News Staff
RALEIGH, N.C. – Nearly three months after being acquired by Valeant Pharmaceuticals International Inc. , Sprout Pharmaceuticals‘s sexual-desire drug Addyi has been somewhat dormant when it comes to sales, with only 227 prescrptions in the first few weeks it’s been available by prescription, Bloomberg reported this morning.
Addyi, which was approved in late summer by the U.S. Food and Drug Administration (FDA), hit the market on Oct. 17. HSDD is defined as a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance. However, the number of women diagnosed with HSDD is rather small, Jonathan Schaffir, an ob/gyn at the Ohio State University Wexner Medical Center in Columbus, told Bloomberg. Schaffir, who helped run clinical tests on the drug before Sprout acquired it, told Bloomberg none of his patients have inquired about Addyi.
Although the female sex drug is not truly comparable to Pfizer Inc. ’s sexual enhancement blockbuster drug Viagra, that medication was prescribed more than 500,000 times in its first week, Bloomberg said. Viagra and Eli Lilly and Company ‘s Cialis had combined revenue of nearly $4 billion in 2014. Unlike the drug’s oft-compared male counterpart Viagra, Addyi addresses desire, not performance. Another difference between male erectile dysfunction drugs, Addyi is a once-daily dose that takes some time before the patient begins to see a difference in sexual desire. In clinical trials, patients began to show desire after about four weeks.
Before Addyi was approved, the FDA turned it down several times, once when the drug was owned by Boehringer Ingelheim and rejected in 2010. Regulators issued a Complete Response Letter that essentially said the drug would not be approved in its present form. Sprout acquired the drug in 2011 and its efforts were also rejected by the FDA in 2013. After two more years of study, the FDA finally backed the drug’s approval, although it comes with the “black box warning” label due to serious side effects, including severely low blood pressure that can cause individuals to pass out. The side effects are increased if alcohol is consumed.
In addition to the smaller number of women diagnosed with HSDD and the side effects, Bloomberg pointed out cost may also be a factor. A monthly treatment of the once-per-day medication is approximately $800. Valeant, the parent company of Sprout, has been under fire for raising the prices of prescriptions after it acquires companies. Some insurers told Bloomberg they were not covering Addyi, or were placing it on their higher cost tiers. Sprout told Bloomberg it has a patient assistance program that will provide Addyi for about $20 per month.
After Addyi was approved, Sprout said the medication will only be able to be prescribed by pharmacies certified by Sprout and will require training on counseling patients on the risks and side effects, especially the interaction with alcohol. So far the company has been able to train 5,600 physicians, about 1 percent of obstetricians and general practitioners who might be able to prescribe the drug, Bloomberg said.
Valeant acquired Sprout for $1 billion just days after Addyi was approved by the FDA. When the deal was announced, Michael Pearson, the now embattled chief executive officer of Valeant, said the acquisition of Sprout will allow Valeant to “establish a new portfolio of important medications that uniquely impact women.” Cindy Whitehead, the chief executive officer of Sprout, said becoming part of Valeant will provide a seasoned distribution line that can provide women across the globe access to Addyi.
