Lowest Dose Oral Contraceptive for Preventing Pregnancy -- LOLO™ -- Now Available in Canada

OAKVILLE, ON, June 26, 2014 /CNW/ - As scientific evidence has accumulated, there has been a movement toward lower dose estrogen formulations of combined oral contraceptives, which demonstrate similar efficacy with fewer side effects than higher dose options.1 Actavis Specialty Pharmaceuticals Co. today announced the Health Canada approval and availability of LOLO™ (ethinyl estradiol and norethindrone acetate tablets), a new low-dose oral contraceptive indicated for the prevention of pregnancy that uses only 10 micrograms (mcg) of estrogen — the lowest dose of any combined oral contraceptive.

"Women who require birth control are often concerned about the amount of hormones in the various contraceptive methods. LOLO™ is a new safe and effective oral contraceptive pill that provides another choice for Canadian women looking for an oral contraceptive pill, particularly one with less estrogen," says Dr. Amanda Black, obstetrician-gynecologist at the Ottawa Hospital.*

LOLO™ is the first and only oral contraceptive to combine 10 mcg of ethinyl estradiol with 1 milligram (mg) of a trusted progestin, norethindrone acetate.2 In addition, it has a unique 24/2/2 dosing regimen which provides 24 days of active pills containing 10 mcg estrogen and 1 mg of norethindrone acetate to provide effective contraception3, two days of 10 mcg of estrogen that may limit estrogen fluctuation and side effects and two days of placebo for a short hormone-free interval. A short hormone free interval has been associated with less follicle maturation and escape ovulation.4

The Health Canada approval of LOLO™ was based on a large, one-year (thirteen 28-day cycles) multicenter Phase 3 open-label clinical trial of 1,582 women who were 18 to 45 years of age.5 During the trial, participants' periods remained fairly constant over the one year study, with an average of less than two days per cycle.6 LOLO™ had a low rate of adverse reactions with breast tenderness, acne, weight change and nausea all reported in fewer than five per cent of trial participants.7

"The approval of LOLO™ in Canada offers a meaningful advancement in oral contraception," said Rob Tessarolo, General Manager, Actavis Specialty Pharmaceuticals Co. "Actavis is committed to women's health and bringing innovative products to enable patient choice and fulfill the medical needs of Canadian women."

About Actavis, Inc.
Actavis, Inc.is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has global and U.S. headquarters in Parsippany, New Jersey, USA.

Actavis Specialty Pharmaceuticals Co. is the Company's branded specialty pharmaceutical business engaged in the marketing, sale and distribution of specialty pharmaceutical products within the Canadian market and has its head office in Oakville, Ontario. Actavis Specialty Pharmaceuticals Co. is focused on delivering innovative products that address key therapeutic categories in urology, gastroenterology and in women's health. 

*Dr. Black was not compensated for her statement. She has been a paid consultant to Actavis Specialty Pharmaceuticals Co.

References:

1 Cerel-Suhl SL, Yeager BF. Update on oral contraceptive pills. Am Fam Physician. 1999;60:
2073-2084.
2 LOLO Product Monograph.Page 3.December 2013.
3 Farrer F. Contraception – a review. SA Pharmaceutical Journal. 2009;76(6):18-22
4 Klipping C, et al. Contraception. 2008; 78:16-25.
5 LOLO Product Monograph.Page 30. December 2013.
6 LOLO Product Monograph.Page 32. December 2013.
7 LOLO Product Monograph.Page 14. December 2013.

SOURCE: Actavis Specialty Pharmaceuticals Co.

For further information: or to arrange an interview with Dr. Black, please contact: Erin Collett, Edelman, Erin.collett@edelman.com, 416-849-8911

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Actavis Specialty Pharmaceuticals Co.

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