Sept 11, 2019, 11:30am ET

Summary of Recent Regulatory Guidance for Addyi, the First and Only Pill for Hypoactive Sexual Desire Disorder

The following provides a recent timeline of events between the U.S. Food and Drug Administration (FDA) and Sprout Pharmaceuticals as it relates to the FDA's statements on Addyi’s labeling.

April 11, 2019: FDA Order and Press Release
On April 11th, the FDA ordered important labeling changes for Addyi® (flibanserin) instructing Sprout as well as informing women and their healthcare providers as follows: “Based on the results of post marketing studies, the FDA has determined that changes must be made to Addyi’s labeling to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely. Specifically, the boxed warning, contraindication, warnings and precautions, and adverse reactions sections of labeling are being updated to reflect that women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.”

April 11, 2019 – August 18, 2019: The FDA Appeal Process
On April 11th, the same day that the FDA issued its public statements, Sprout initiated the FDA appeal process to also get agreement for removal of the alcohol contraindication, or ban, and the restrictive elements of the REMS (known as ETASU) such as having women sign an attestation saying they will abstain from alcohol. That appeal process concluded on August 18th with a final decision from the Office of New Drugs at FDA stating their agreement on these two points.

Specifically, the Director of FDA’s Office of New Drugs stated, “My assessment is that the new information narrows the risk of the flibanserin-alcohol interaction and that a [boxed warning] and a verifiably comprehensible medication guide should provide appropriate management of the risk. Based upon this, a REMS that includes a medication guide, but not ETASU, is appropriate to ensure that the benefits outweigh the risks. The company should submit a request to modify the REMS, as described above.” Regarding the Contraindication, the Director stated, “The labeling should, therefore, be revised so that the [contraindication] is limited to women on moderate or strong CYP3A4 inhibitors or who have hepatic impairment, populations for whom the benefit of treatment do not outweigh its risks. The Company can submit a proposed revised labeling that removes the contraindication for use of alcohol with flibanserin.”

August 29, 2019:
Sprout complied with the FDA’s request and submitted all required paperwork to modify the labeling and REMS within 11 days. Sprout submitted a CBE-0 supplement implementing the FDA’s April 11 language and removing the contraindication and reference to ETASU from the labeling in accordance with the appeal decision. Sprout also submitted a REMS modification supplement to replace the ETASU with a medication guide.

September 4, 2019 - Present
Sprout issued a press release announcing these events the week following their finalized submission and two weeks after receipt of the Office of New Drugs final decision letter. The new labeling language that Sprout announced is consistent with the language FDA laid out on April 11th and included the update from FDA’s appeal decision as it relates to removing the alcohol contraindication and language about the ETASU. On September 6th, FDA informed Sprout that it objected to our press release and asked that we take the release down. In an effort to be cooperative, Sprout took its release down early on September 7th. Starting September 10th, FDA began alerting media outlets that “at this time” FDA has not made these changes. Sprout issued this timeline of events for absolute clarity. We look forward to working with the FDA through this implementation phase and are hopeful that FDA will quickly initiate discussions with the company about its submissions and implementation of decisions already reached in the best interest of doctors and patients to avoid unnecessary confusion.

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 first and only FDA approved pill for women with Hypoactive (low) Sexual Desire Disorder (HSDD). For more information call 1-844-PINK-PILL (1-844-746-5745).

ABOUT ADDYI
Addyi is the first and only FDA-approved pill for acquired, generalized hypoactive (low) sexual desire disorder (HSDD) for premenopausal women. Addyi is the only treatment for HSDD that has successfully demonstrated that it adds more satisfying sexual events, adds more desire for sex and reduces distress from the loss of sexual desire in clinical trials. The most common adverse events among patients treated were dizziness, sleepiness, nausea, fatigue, insomnia and dry mouth. Patients are advised to discontinue drinking within two hours of taking Addyi at bedtime or skip the Addyi dose that evening. Addyi is a novel, non-hormonal pill. See full prescribing information and medication guide at addyi.com/pi.

CONTACT INFORMATION
info@sproutpharma.com
844-746-5745 x 2000