FDA approves the ‘female viagra’ Addyi !
The FDA has approved a drug aimed to enhance female sexual drive or resolve female sexual disorder. The drug is being marketed by Sprout Pharmaceuticals under the name ‘Addyi’ (generic name: Flibanserin). Here are a few details about it:
Generic & Brand Name: Flibanserin; Addyi
Marketed by: Sprout Pharmaceuticals- (Raleigh, North Carolina, U.S.A)
First of its kind – Addyi is the first drug approved to treat a flagging or absent libido. More specifically it has been approved for generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval there were no FDA-approved treatments for sexual desire disorders in men or women.FDA’s approval of the drug to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
Addyi, Flibanserin marketed by Sprout Pharma
Mechanism of Action: Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.
Efficacy: The effectiveness of the 100 mg bedtime dose of Addyi has been evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4).
On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo.
Additional analyses explored whether the improvements with Addyi were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.
Side Effects: Addyi can cause hypotension and syncope. Both of these adverse effects are potentiated by alcohol and other CYP3A4 inhibitors. The most common adverse reactions are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth. It is also contra indicated in patients with liver impairments.
Cost: A Sprout executive told the New York Times that it plans to charge the same price as erectile dysfunction drugs, roughly $400 a month. However, Viagra and Cialis are taken on demand, whereas Addyi must be taken daily making its annual cost close to $5,000/patient. Insurance companies may not be willing to reimburse patients this amount of money for a drug that provides a modest benefit for the majority who take it. Even if payers cover a portion of the cost, as happens with erectile dysfunction drugs, will patients be willing to pay $75 a month or more.
Availability: Because of a potentially serious interaction with alcohol, treatment by the pill can be prescribed or dispensed only by doctors and pharmacists who watch an online slide presentation and pass a test of their comprehension.There will most likely be an initial surge of prescriptions for Addyi but, after a few months sales may decline due to its limited efficacy and safety profile which puts even casual drinkers at risk of- low BP and fainting. People with liver impairment too should not use the drug it is not to be combined with certain other drugs . Moreover it is believed that,Addyi won’t come close to meeting the needs of the female sexual dysfunction population as Viagra and Cialis did for erectile dysfunction as its effectiveness is not seen as being remotely close to those.
Image Credit – dailymail.co.uk
