Mar 21, 2019, 07:00 ET
Sprout Pharmaceuticals Presents Important New Addyi Safety and Tolerability Data through Three Alcohol Interaction Studies in Which There Was No Syncope or Orthostatic Hypotension Requiring Medical Attention and No Increase in Adverse Events of Special Interest
Multiple studies and new data clarifying the Addyi and alcohol interaction for both the medical community and patients were formally submitted to the FDA as well as presented to The International Society for the Study of Women's Sexual Health (ISSWSH), International Society for Sexual Medicine (ISSM) and Sexual Medicine Society of North America (SMSNA).
LOS ANGELES, March 21, 2019 /PRNewswire/ -- Sprout Pharmaceuticals, Inc. ("Sprout") today announced the results from three studies evaluating the interaction between and alcohol and Addyi, the first and only FDA approved treatment of acquired, generalized Hypoactive (low) Sexual Desire Disorder (HSDD) in premenopausal women. In clinical trials, Addyi demonstrated improvements in desire for sex, reduced distress from the loss of sexual desire and increased the number of satisfying sexual events. The recently presented results from these new studies add to the understanding of Addyi as a treatment for HSDD – the most prevalent form of sexual dysfunction in women.
"The additional insights provided by these three new studies are invaluable for a more comprehensive understanding of Addyi for safe use. This additional data contextualizes and further clarifies the relationship between Addyi and alcohol. We thank all of the women who participated in these informative studies." said Cindy Eckert, Founder and CEO of Sprout Pharmaceuticals.
The first study resulted in no increased incidence of adverse events of special interest in the women when they received Addyi (flibanserin) 100mg a couple of hours post alcohol compared to when they received placebo post alcohol. The study was conducted in 24 healthy premenopausal women and designed to simulate a real-world scenario in which women drank alcohol with their evening meal and then took Addyi approximately 2.5 hours later at bedtime as indicated. For the first three days women took either Addyi or placebo to get to steady state. On Day 4 and Day 6, women consumed the equivalent of two servings of alcohol or two servings of a matched nonalcoholic beverage during the course of their evening meal. Approximately 2.5 hours later they took Addyi or matching placebo at bedtime, five minutes before going to bed. This study was designed to assess whether bedtime dosing of Addyi was effective in managing the risk of syncope and severe hypotension that was observed in the preapproval Phase 1 study. In this more recent study no women experienced adverse events of special interest such as syncope.
A second study involving 96 healthy premenopausal women was designed to assess the effect of the approved dose of Addyi co-administered with varying doses of alcohol on dizziness, syncope, and hypotension. The study was designed to be a worst-case scenario alcohol interaction study in which Addyi was taken at the same time as 2-3 shots of grain alcohol mixed with orange juice. The alcohol was consumed within 10 minutes in the morning following an overnight fast and a light snack. No episodes of syncope or orthostatic hypotension requiring medical intervention were observed during this study. An observed increase in drowsiness following administration of Addyi, with or without alcohol, supports the recommended bedtime dosing.
Finally, a dose-timing study in 64 healthy premenopausal women designed to evaluate the impact of the timing of alcohol consumption on the safety and tolerability of Addyi was also conducted. A single daily dose of either Addyi 100 mg or placebo was administered for three consecutive days to achieve steady state. On Days 4, 6, 8, and 10, women consumed a moderate dose of alcohol (equivalent to 2 alcoholic drinks) 2, 4, or 6 hours prior to the administration of the drug or placebo. Consistent with the findings of the other studies there were no episodes of syncope or orthostatic hypotension requiring medical intervention observed in this study. In addition, the administration of a moderate dose of alcohol 2, 4, or 6 hours prior to Addyi 100 mg at steady state did not increase the incidence of other adverse events of special interest.
The FDA-approved Package Insert contains a boxed warning contraindicating the consumption of any alcohol while taking Addyi due to an increased risk of syncope and hypotension. These new, more recent results were submitted to FDA to inform safety labeling. All three studies advance the understanding of the safety and tolerability of Addyi for the FDA, the medical community and women in need of treatment.
ABOUT SPROUT PHARMACEUTICALS
Sprout Pharmaceuticals, Inc. is passionate about women's sexual health. Based in Raleigh, N.C., the company is focused solely on the delivery of a treatment option for women with HSDD. For more information call 1-844-PINK-PILL (1-844-746-5745).
Addyi is the first and only FDA-approved treatment for acquired, generalized hypoactive (low) sexual desire disorder (HSDD) for premenopausal women. In clinical trials, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events. The most common adverse events among patients treated with Addyi were dizziness, somnolence, nausea, fatigue, insomnia and dry mouth. Hypotension, syncope, and central nervous system (CNS) depression were seen with Addyi alone and more frequently when co-administered with alcohol in the morning, or certain other drugs. Alcohol consumption is contraindicated for women taking Addyi. With the FDA, Sprout Pharmaceuticals developed a comprehensive Risk Evaluation and Mitigation Strategy (REMS) program, including prescriber and pharmacist certification, to ensure safe use of Addyi. Addyi is a novel, non-hormonal oral pill to be taken at bedtime. See full prescribing information, including Boxed Warning regarding the use of alcohol, severe low blood pressure, and fainting in certain settings, at addyi.com/pi.
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