Contraceptives

Thank you to Diane Rubino of The Population Council (pubinfo@popcouncil.org) for updating and supplying the additional information for this topic. The previous post with this title has been deleted so as not to cause any confusion with the current status on this issue.
The information has been directly supplied to me by the Office of Public Information at the Population Council.

The future is looking bright for the soon to be available new contraceptive for women- the contraceptive spray. Companies on opposite sides of the globe, Acrux Pharmaceuticals (West Melbourne, Australia) and The Population Council (New York, NY) have combined their products and expertise to develop a revolutionary way of blocking ovulation.

The contraceptive spray is still under development. It has not yet completed the safety and effectiveness testing that is required by the FDA before the agency determines whether or not a product should be put on the market.

Effective, safe and appealing-these are the main elements women want in their range of contraceptives

Igor Gonda PhD and now ex CEO of Acrux Ltd, stated in 2005, “The Population Council and Acrux are developing this new product because we believe that we will provide many women with an attractive choice of contraception that could be convenient, effective, and have no or few side effects”.

Results from the initial phase are positive, with the Population Council’s “Nestorone” (estradiol) being administered via Acrux’s patented spray.

The Council’s Nestorone®, a progestin, is combined with a natural estrogen, estradiol, which are administered via Acrux’s patented spray technology.

The solution containing Nestorone and estradiol is sprayed onto the skin each day in a measured amount, is absorbed into the bloodstream and blocks ovulation.

Nestorone is a derivative of the natural progesterone, and is combined with a natural estrogen, unlike the hormones currently used in oral contraceptives and the patch.

The hormones are ‘carried’ in an alcohol base that also contains a ’skin penetration enhancer’.

Advantages of the spray

Acrux had previously developed a spray delivering the natural estrogen estradiol to be used for postmenopausal hormonal therapy. Now approved by the FDA, the spray may be on the market by next Christmas. It is expected to be on the market by the first quarter of 2008, probably under the name “Evamist” for treatment of postmenopausal symptoms.

The same spray technology is being evaluated to deliver a combination of Nestorone and estradiol for contraceptive purposes.

• The contraceptive is sprayed onto the inside of the forearm, where it dries within a minute. Then the hormones Nestorone and estradiol are slowly released into the bloodstream over a period of time.

• A woman may have more flexibility with WHEN she uses it, since the little pool or ‘reservoir’ that forms in the outer layer of the skin supplies the progesterone derivative and estradiol constantly. This ‘reservoir’ is then topped up with the next dose.

• The fluctuations in blood levels will be milder than with traditional pills.

• The TIMING of application will not be as crucial with the spray as with the oral contraceptive,(which should be taken at approximately the same time each day to be most effective)due to the fact that one dose of Nestorone will be distributed to the body steadily over a 24-hour period.

NATURAL hormones such as Nestorone and estradiol are used in the spray–not synthetic ones (as in the patch and pills, which previously have been linked to rare cases of cardiovascular disease).

Nestorone is so effective in blocking ovulation that only microgram, rather than milligram doses (found in some contraceptive pills), will be needed.

According to Régine L. Sitruk-Ware, MD, executive director of research and development at the Population Council,“The two natural hormones we use should improve the tolerability and will have much less impact on the liver than products on the market.” Furthermore, the formulation may also be suitable for breastfeeding women because the compound Nestorone cannot be orally absorbed and will not harm infants.

Fewer Side Effects

Researchers are optimistic that the contraceptive spray will be far more ‘user friendly’ than the birth control pill or the contraceptive ‘patch’ as it will eliminate some side effects.

Nausea (which makes some women skip doses of the pill) in particular will not occur because nothing is taken down the gastrointestinal tract to the stomach.

We don’t yet know what the conditions of use will be (no swimming after spraying?!!!)but this method of contraception is under development to evaluate the efficacy and safety in women seeking contraception. It is to be hoped that when the final phase of clinical trials is completed, the spray will be very affordable (lower dose = lower price?) This is an important milestone for the contraceptive market–and why wouldn’t it be? Worldwide sales of hormonal contraceptives in 2006 were around $6.7 billion!

Source: The Population Council