CHARLESTON, S.C.--(BUSINESS WIRE)--Please replace the release with the following corrected version due to revisions.
The corrected release reads:
AFAXYS ANNOUNCES WIDER NATIONAL AVAILABILITY OF ELLA® EMERGENCY CONTRACEPTIVE
Afaxys Pharmaceuticals, a division of Afaxys, Inc., today announced wider U.S. availability of ella® (ulipristal acetate), a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
“ella is a first-of-its-kind product that offers a proven method to help prevent pregnancy before it starts. It’s exciting that this new generation emergency contraceptive with proven safety and tolerability in over 1.4 million women in Europe is now available to U.S. women,” said Cheryl Gibson, MD, medical director for Afaxys. “ella’s unique features offer the prevention that women require and deserve, and we are proud to see the product become available to work as an integral part of a women’s health portfolio.”
Available via prescription by both health providers and pharmacists, ella is a single tablet that works primarily by delaying or preventing ovulation. ella remains effective at delaying or preventing ovulation for up to five days after unprotected sex or birth control failure – providing women with the extra time they may need to help prevent pregnancy. This is longer than any other oral emergency contraceptive option on the market.
“We’re excited to offer wider national access for ella,” said Ronda Dean, president and CEO of Afaxys. “Afaxys has a strong track record of working to make a difference in women’s health, and we are well-positioned to expand access to emergency contraception for all women nationwide. ella is critical for women and we are focused on providing an affordable, continuous supply of ella especially for public health providers like urgent care centers, clinics, emergency rooms, and student health centers to meet women’s healthcare needs.”
ella is available to patients by prescription through their medical and other public health providers or some pharmacists. Consumers seeking ella will be able to find it quickly by seeing a healthcare professional in locations such as:
- City, County and State Facilities,
- College and University Health Centers,
- Community Health Centers,
- Doctor’s Offices,
- Emergency Rooms,
- Independent Family Planning Centers,
- Planned Parenthood Facilities, and
- Urgent Care Centers.
Pharmacists can now order ella directly from Cardinal Health at www.cardinal.com or by calling 1.800.326.6457; order #5029780. ella is also available through the following distributors:
|Web Address||Phone||Order Number|
|Anda, Inc.||1-800-331-2632, ext. 7422||#50102091101|
In some states, consumers may access emergency contraception like ella directly from a pharmacist. In Alaska, California, Hawaii, Massachusetts, New Hampshire, Vermont, and Washington, pharmacists may dispense ella without prescription under a collaborative practice agreement. Additionally, pharmacists in California, Maine, and New Mexico may dispense ella without prescription under their state-approved protocols, as well.
For more information on ella and Afaxys products, please visit http://pharma.afaxys.com.
Afaxys, Inc. is a mission-driven, public health-focused social-business enterprise, established by and focused on serving the needs of millions of women dependent on public health providers for their reproductive healthcare needs. Since 2005, Afaxys has operated a Group Purchasing Organization, and in 2013, launched its pharmaceutical division, Afaxys Pharmaceuticals (AP). AP brought a number of affordable oral contraceptives to the women’s healthcare market. The Company has an expanding portfolio of FDA-approved pharmaceuticals, including the recently launched ella®, a progesterone agonist / antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Please see the full ella Prescribing Information at https://pharma.afaxys.com/afaxys/assets/pdf/ella%20SPL%20FINAL%2031Mar14-%20approved%20CG.pdf. To learn more, visit http://pharma.afaxys.com.
Important Safety Information
The most common adverse reactions (≥5%) in the clinical trials were headache (18%), abdominal pain (12%), nausea (12%), dysmenorrhea (9%), fatigue (6%), and dizziness (5%). ella is contraindicated in women with a known or suspected pregnancy and should not replace a regular method of contraception. Repeated use of ella within the same menstrual cycle is not recommended. ella is not indicated for termination of an existing pregnancy. Women who become pregnant or complain of lower abdominal pain after taking ella should be evaluated for ectopic pregnancy. ella may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be ruled out. A rapid return of fertility is likely following treatment with ella; therefore, routine contraception should be continued or initiated as soon as possible to ensure ongoing prevention of pregnancy. Please note that due to the high binding affinity of ella to the progesterone receptor, it may reduce the contraceptive action of regular hormonal contraceptive methods. Therefore, after use of ella, a reliable barrier method of contraception should be used with subsequent acts of intercourse that occur within the same menstrual cycle of the emergency contraceptive use. ella does not protect against sexually transmitted diseases or HIV.
Please see the full Prescribing Information at https://pharma.afaxys.com/afaxys/assets/pdf/ella%20SPL%20FINAL%2031Mar14-%20approved%20CG.pdf.
Afaxys Disclosure Notice
This press release was issued in the United States and is intended as reference information for U.S. journalists and customers. The information contained in this Afaxys press release is accurate at the time of issuance, and the company assumes no responsibility for updating forward-looking statements to reflect subsequent developments.