CONCORD, ON, Aug. 3, 2016 /CNW/ - Pursuant to the numerous articles published since the approval of Mifegymiso (mifepristone/misoprostol) by Health Canada on July 29, 2015, the Canadian distributor, Celopharma Inc., in collaboration with the sponsor, Linepharma International Limited, would like to provide an official update of the Canadian situation.
Mifegymiso is provided in a pack containing two different drugs: mifepristone, which has an anti-progesterone activity, and misoprostol, which causes the contraction of the uterus. Mifepristone must be taken first, followed 24 to 48 hours later by misoprostol. When appropriately taken, the efficacy of Mifegymiso is between 95-98%.
Similarly to the applications to Foreign Health Agencies for other abortion pills, at the time of application (2012), Linepharma has suggested the following Risk Minimization Strategies to Health Canada, which were agreed:
- a Restrictive Distribution and Administration Program;
- an Education and Registration Program for Mifegymiso prescribers;
- a Canadian Phase IV observational study of Mifegymiso safety;
- a 24-hour support-line in both English and French for patients taking Mifegymiso;
- a Patient Consent Form to be provided to each patient by the authorized prescriber;
- a Patient Medication Information and a Patient Information Card to be provided to each patient by the authorized prescriber.
The review of the Mifegymiso, even though it was challenging, was performed in great collaboration with Health Canada, which is ongoing and will continue throughout the lifecycle of Mifegymiso.
Restrictive Distribution and Administration Program
Only trained and certified physicians can prescribe Mifegymiso. Due to the novelty of the medication in Canada, the effect of the drug (abortion), contraindications and risks (infection/sepsis, prolonger heavy bleeding, etc.), the training program will ensure that physicians have access to all relevant information regarding the procedure and the new medications prior to prescribing Mifegymiso to minimize risk for patients.
The mifepristone tablet, included in the Mifegymiso pack, has to be taken under the supervision of a healthcare professional (physician). Indeed, the timing for taking mifepristone tablet is critical (less than 49 days of gestational age) as it correlates with the efficacy of the drug (the more you wait, the less efficient the drug is). This restrictive administration program is in place in order to give the appropriate medical and psychological support to women, to ensure that the drug is not taken too late during the pregnancy and to be able to schedule a follow-up appointment in the appropriate delay. Note that the misoprostol tablets can be taken at home, within 24-48 hours after taking mifepristone.
To ensure that women take the medication under the supervision of their healthcare professional, Mifegymiso will not be available in retail pharmacies for direct distribution to women. However, certified pharmacies can stock and ship the medication to prescribers' offices.
A Supplemental New Drug Submission (SNDS) is under preparation and will be submitted later this year, in order to modify the terms of the marketing authorization, which includes the Restrictive Distribution Plan and Administration Program.
Due to issue with the availability of one of the drugs, it is anticipated that Mifegymiso will be available in Fall 2016.
Celopharma Inc., is a privately held, Canadian owned pharmaceutical company specializing in the licensing, regulatory, marketing and distribution of niche pharmaceutical products with their primary focus on women's health. www.celopharma.com
SOURCE Celopharma Inc
For further information: Paula Tenenbaum, Celopharma Inc., 1-877-230-4227, www.celopharma.com