Menstrual-suppressing drug gets Canadian okay


In U.S. since 2003. Extended-cycle oral contraceptive
The Gazette
Business Section Montreal, Canada
Friday, July 06, 2007

Montreal specialty pharmaceutical firm Paladin Labs Inc. has got the federal government’s green light to market the first extended-cycle oral contraceptive in Canada that allows women to suppress menstruation.
Seaonale, or levonorgestrel and ethinyl estradiol tablets, were approved for sale by Health Canada’s Therapeutic Products Directorate yesterday. The drug has been available in the U.S. since 2003.
“We’re excited about it,” Mark Beaudet, Paladin vice-president of sales and marketing, said yesterday, noting the Canadian oral contraceptive market is worth more than $300 million annually.
“It’s going to be a very good product for us,” predicted company president Jonathan Goodman. “It will really improve the lives of Canadian women.”
Women using the prescription would reduce the number of menstrual periods in a year from 13 to four. The prescription includes a course of 91 doses, with 84 active tablets, followed by seven inactive, during the course of which the woman would have her period. This compares with the current oral contraceptives on the market that contain 21 active and seven inactive pills.
But at a meeting in Vancouver last month, members of the Society for Menstrual Cycle Research said menstruation is not a disease and further research on the potential health risks and long-term safety of cycle-stopping contraception is needed.
Society member Laura Wershler said yesterday: “Women have to ask themselves if it’s in their best interest and what are the health implications.”
Wershler, executive director of the Sexual Health Access Alberta (formerly Planned Parenthood) office in Calgary, added there’s still “a need to know more about the health benefits and potential risks such as bone, breast and cardiovascular health.”
While she acknowledges products like Seasonale can be helpful for women with menstrual cycle disorders, she questions the “choice for convenience sake.”
The society concluded June 8 that “arguments for cycle-stopping contraception often describe debilitating menstrual cramps and heavy flow as indications, but promote routine use by all women who would prefer not to menstruate for matters of convenience.”
Bruce Downey, chairman and chief executive of Barr Pharmaceuticals Inc., said in a statement released yesterday from headquarters in New Jersey: “We are confident that Paladin will be able to effectively communicate the benefits of the Seasonale regimen to this exciting new (Canadian) market.”
Barr announced in October 2005 that its subsidiary Duramed Pharmaceuticals Inc. signed a licence and distribution deal with Paladin for Seasonale.
Farrukh Rehan, women’s health marketing manager at Paladin, said Seasonale sales south of the border were $85 million U.S. in 2005 and $120 million last year.
Sue Cavallucci, spokesperson for IMS Health Canada, which provides information and analysis for the health-care community, pointed out the estimated dollar value of oral contraceptives was nearly $308 million last year – almost $90 million in Quebec.
The Gazette (Montreal) 2007



Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.