Addyi (flibanserin), the FDA-approved treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women, will be relaunched with a new, reduced price of $400, down from $800 (for a monthly prescription).
The relaunch was announced by the drug’s manufacturer Sprout Pharmaceuticals, after they won a lawsuit to take back control from Valeant Pharmaceuticals – who they sold to in 2015 for $1 billion. Sprout sued Valeant for falling behind on its obligations to deliver a portion of Addyi profits to Sprout’s former owners.
Addyi is a once-daily, non-hormonal drug that is the first post-synaptic 5HT1A receptor agonist and 5HT2A receptor antagonist available for female HSDD. Controversy has surrounded Addyi since its launch in 2015, after it faced the FDA’s advisory committee panel for review of efficacy and safety issues a total of 3 times before approval. The treatment carries a Boxed Warning for an increased risk of severe hypotension and syncope when taken with alcohol.
For the relaunch, Sprout is incorporating a telemedicine system; patients can be evaluated, diagnosed and prescribed the treatment by licensed doctor over the telephone or online. Prescriptions can also be received by mail. Only REMS certified healthcare providers and pharmacies can prescribe or distribute Addyi.
While the mechanism of action for flibanserin in the treatment of HSDD is unknown, it is thought to work by restoring prefrontal cortex control over the brain’s motivation/rewards structures enabling sexual desire to manifest.
A New Drug Application (NDA) was submitted earlier this year for bremelanotide (Palatin Technologies) another proposed treatment of HSDD in premenopausal women. The FDA has set a Prescription Drug User Free Act date of March 23, 2019.
For more information visit Addyi.com.