First chewable OC enters U.S. market

Successful pill-taking is an important component for women who use oral contraceptives (OCs). Inconsistent use and method discontinuation are estimated to account for approximately 20% of the annual 3.5 million annual unintended pregnancies in the United States.1

Will a chewable contraceptive aid in pill-taking compliance? The Food and Drug Administration (FDA) has just approved the first such product. Look for the launch of Ovcon 35 in late spring, says Katie MacFarlane, PharmD, vice president of marketing for Galen Holdings and Warner Chilcott, based in Rockaway, NJ.

When a pill is reformulated into a chewable form, it must be flavored to mask the chalky taste of the active ingredient, says Jeff Worthington, managing director of food and pharmaceutical technologies at Cambridge, MA-based TIAX, an independent and privately held technology development and consulting firm that aids companies in developing palatable pharmaceuticals, nutritional products, foods, and beverages.

Taste equals compliance

Flavor quality is key to good compliance, he states. If the product does not taste good, the patient won’t be willing to follow the course of treatment, Worthington observes.

"Good flavor quality becomes even more important on chronic exposures rather than acute," he explains. "You could live with your 10 doses of antibiotic, but if you have to take it every day, flavor quality is going to be important."

What led the company to develop the chewable OC?

"Warner Chilcott recognizes that women continue to seek out new options for contraception; also, the main cause of oral contraceptive failure is women forgetting to take their tablets, and a high percentage of current oral contraceptive users miss at least one tablet per cycle," says MacFarlane. "Ovcon 35 chewable tablets provide women a new option."

The new chewable pill will carry the same formulation of 35 mcg ethinyl estradiol and 0.4 mg norethindrone as the existing tablet form of Ovcon 35. The Ovcon 35 chewable tablets will be priced competitively with existing OCs and the current Ovcon 35 pill, she reports.

Does the new formulation of Ovcon have any impact on its contraceptive efficacy?

The formulation of estrogen and progestin in the Ovcon 35 chewable tablets is identical to that of the currently available Ovcon 35, answers McFarlane. Bioequivalence studies were performed to gain the approval from FDA; these studies have not yet been published, she states.

The spearmint-flavored Ovcon 35 will be available in a 28-day regimen, with each package containing 21 round, white tablets with norethindrone and ethinyl estradiol, followed by seven reminder green inactive tablets to complete a four-week-cycle. Package instructions state that the pill may be swallowed whole or chewed and swallowed. If the pill is chewed and then swallowed, a full glass (8 ounces) of liquid should be ingested immediately afterward so that the full dose of medication reaches the stomach and no residue is left in the mouth.2

Chewable, flavored pharmaceuticals have become popular in pediatric formulations, as evidenced by children’s flavored aspirin and vitamins. But where does a chewable, flavored OC fit into the spectrum of birth control?

Such products are becoming more commonplace as companies are looking to provide their adult customers with dosage options so they do not always have to take the same form all the time, says Worthington. While his company did not work with the Ovcon 35 formulation, it has been involved in development of palatable oral dosage forms for a wide variety of drugs in clinical development, from HIV therapies to antibiotics.

Whether women chew a tablet or take a pill, the most important aspect when it comes to OCs is strict adherence to the daily dosing regimen. Recent research confirms that compliance problems are common among all age groups, with 47% of women missing one or more pills per cycle, and almost a quarter (22%) missing two or more pills per cycle.1

In one study, poor compliance was associated with a lack of established routine for pill-taking and failure to read and understand written materials that came with the OC package.3 Those who understood little or none of the instructions were 2.4 times more likely to be among women who missed two or more pills per cycle.3

How can you help patients become more successful with pill-taking? Compliance has been linked to patient satisfaction with the clinician, the absence of certain side effects, establishing a regular daily routine to take OCs, and reading information distributed with OC packaging.1

Focus your patient counseling on the transience of most side effects, offer instructions on dealing with a missed pill, provide a backup method, and help women establish a daily pill-taking routine.1 Be sure to provide easy-to-understand literature for women to take home.

References

1. Rosenberg M, Waugh MS. Causes and consequences of oral contraceptive noncompliance. Am J Obstet Gynecol 1999; 180(2 Pt 2):276-279.

2. Food and Drug Administration. FDA Approves Ovcon 35 As The First Chewable Oral Contraceptive Tablet For Women. Press release. Washington, DC; Nov. 14, 2003.

3. Rosenberg MJ, Waugh MS, Meehan TE. Use and misuse of oral contraceptives: Risk indicators for poor pill taking and discontinuation. Contraception 1995; 51:283-288.