Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other Events

ME Staff 8-k
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Agile Therapeutics,Inc. (NASDAQ:AGRX) Files An 8-K Other Events
Item 8.01. Other Events.

On October31, 2017, the Company announced additional data from its Phase 3 SECURE trial of Twirla®(AG200-15), an investigational, once-weekly, low-dose hormonal contraceptive patch, which showed women experienced mean decreases in length of bleeding and spotting episodes. These data were presented during an oral presentation by Anita Nelson, MD, Professor and Chair, Obstetrics and Gynecology, College of Osteopathic Medicine of the Pacific, and Co-Principal Investigator of the Agile Therapeutics,Inc., SECURE Phase 3 clinical trial, at the American Society for Reproductive Medicine (ASRM) Scientific Congress& Expo 2017 in San Antonio, Texas, and the abstract was published in Fertility and Sterility.

The presentation reported, among other items, that over 12 months, women on Twirla reported a gradual decrease in the mean total number of bleeding and/or spotting episodes from 6.0 to 4.9 days from cycles two through 13. Scheduled bleeding, or withdrawal bleeding during the patch-free week, decreased from 4.7 days at cycle two to 4.1 days at the end of the trial. The mean number of days of unscheduled bleeding, or breakthrough bleeding, decreased from 6.3 to 5.2 from cycle two through 13. While the duration of scheduled and unscheduled bleeding decreased, the mean number of episodes were consistent during the trial. Only 2.2% of women discontinued from the trial due to bleeding-related adverse events. presented data which showed women experienced mean decreases in length of bleeding and spotting episodes.

SECURE was a Phase 3, one-year, multicenter, single-arm, open-label trial that evaluated the safety, efficacy and tolerability of Twirla in 2032 healthy women, aged 18 and over, at 102 experienced investigative sites across the United States. Agile announced top-line results of the SECURE clinical trial in January2017.The Company’s new drug application (“NDA”) for Twirla is currently under review by the U.S. Food and Drug Administration with a target Prescription Drug User Fee Act (PDUFA) goal date of December26, 2017.

Copies of the press release and presentation are attached hereto as Exhibit99.1 and 99.2 respectively and are hereby incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.


AGILE THERAPEUTICS INC Exhibit
EX-99.1 2 a17-25121_1ex99d1.htm EX-99.1 Exhibit 99.1   Agile Therapeutics Presents Additional Phase 3 SECURE Trial Results for Twirla® at the American Society for Reproductive Medicine (ASRM) Scientific Congress & Expo 2017   Data Suggests Twirla May Decrease Mean Length of Bleeding and Spotting Episodes   PRINCETON,…
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About Agile Therapeutics,Inc. (NASDAQ:AGRX)

Agile Therapeutics, Inc. is a women’s health specialty pharmaceutical company. The Company is focused in the development and commercialization of prescription contraceptive products. The Company has developed a transdermal patch technology, called Skinfusion. The Company’s lead product candidate is Twirla, also known as AG200-15, is a combined hormonal contraceptive (CHC) patch. In addition to Twirla, the Company is developing a pipeline of other new transdermal contraceptive products, including AG200-ER, which is a regimen designed to allow a woman to extend the length of her cycle; AG200-SP, which is a regimen designed to provide a shortened hormone-free interval, and AG890, which is a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen. Each of its product candidates utilizes its Skinfusion technology designed to deliver contraceptive-levels of hormones to the blood stream through the skin over a seven-day period.