August 19, 2015
By Alex Keown, BioSpace.com Breaking News Staff
RALEIGH, N.C. -- Sprout Pharmaceuticals, the maker of the recently approved sexual-desire drug Addyi, will build on its new-found success and rapidly expand employment to 200, the Triangle Business Journal reported Wednesday afternoon.
Cindy Whitehead, chief executive officer of Sprout and a co-founder of the company, said the new employees will focus on educating health care providers about the drug and “setting realistic expectations” for the drug, according to the Journal. Sprout currently employs 34 in its Raleigh headquarters that is, as of now, solely focused on issues surrounding women’s sexual health.
Before Sprout’s lead drug was approved by regulators, the drug had attracted the interest of private investors who laid down $100 million to help develop the drug.
Addyi was approved by the U.S. Food and Drug Administration (FDA) for a low sex drive, called hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike the drug’s often 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.
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.
The drug is expected to become commercially available Oct. 17 and Sprout is also looking to expand markets beyond the borders of the U.S., including Canada and Europe, although when or if regulatory agencies in those areas will approve the medication will have to wait to be seen.
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. When the drug is commercially available, it 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. Additional side effects include dizziness, drowsiness, nausea, fatigue, insomnia and dry mouth.
