WCC Plan B OTC Marketing Partnership Sought Pending Switch Approval

Women's Capital Corporation "is in discussions with a number of potential strategic marketers" to sell an OTC version of its Plan B emergency contraceptive pending approval of the firm's April 21 switch application.

The Washington, D.C.-based firm said it is open to various partnership options, ranging from a distribution agreement to sale of the company. WCC explained it likely would not be able to support a full-scale launch of OTC Plan B on its own, and a partnership would provide the resources for a major promotional campaign.

WCC filed its supplemental NDA to switch the emergency contraceptive over-the-counter after two years of compiling study data and completing the relevant research. Plan B consists of two .75 mg levonorgestrel tablets that are meant to be taken 12 hours apart.

An advertising campaign for OTC Plan B likely would be educational, with ads resembling an infomercial, WCC said. The goal would be to help women better understand when they are and when they are not at risk for pregnancy after engaging in unprotected sex.

WCC anticipates Plan B will retail for just over $30 if FDA approves an Rx-to-OTC switch of the drug. The emergency contraceptive currently costs $27 at pharmacies, the firm noted.

Proposed OTC packaging for Plan B would be almost identical to the Rx version, although the print would be larger and the wording simpler, WCC said.

Labeling would direct consumers to "take the first tablet as soon as possible but no later than 72 hours (three days) after unprotected sex. Take the second tablet 12 hours after you take the first tablet."

Proposed warnings state consumers should not use Plan B "if you are already pregnant (because it will not work); if you are allergic to any ingredient in Plan B; [or] if you have unusual vaginal bleeding." Labeling also notes the drug "does not protect against HIV...or any other sexually transmitted diseases" and "is not recommended for regular contraception."

Potential side effects stated on the proposed "Drug Facts" label include nausea, diarrhea, menstrual changes, vomiting, dizziness, stomach pain, breast pain, tiredness and headache.

WCC's switch application includes 39 studies on almost 11,000 women, the firm said. The submission provides FDA with a label comprehension study, an actual use study and various clinical and behavioral trials on the emergency contraceptive.

The label comprehension study, which was published in a December issue of The Lancet, demonstrated 96% of women understood that the two levonorgestrel tablets should not be taken at the same time, and 86% understood the pills should be taken at a 12-hour interval (¹ (Also see "Plan B Switch NDA Could Be Supported By New Study Findings" - Pink Sheet, 6 Jan, 2003.), p. 4).

A separate mall-intercept label comprehension study published in Obstetrics & Gynecology showed that 93% of women understood Plan B is intended to prevent contraception up to 72 hours after unprotected sex and should not be used by women who are already pregnant (² (Also see "Plan B Label Comprehension, Actual Use Studies Completed" - Pink Sheet, 26 Aug, 2002.), p. 6).

The actual use study has not yet been published, although the firm expects it to appear in a summer issue of the Green Journal. Primary endpoints of the trial were incorrect use of Plan B or use of contraindicated drugs, while secondary endpoints included pregnancy, side effects, repeat use and impact on regular contraception.

The firm noted it did not need to change the Plan B label after evaluating results of the actual use study.

The behavioral research component of the switch application includes roughly five "advanced provision" studies and five pharmacy-access studies. These trials investigated women's behavior once they are granted easier access to emergency contraception, WCC said.

The bulk of the supplemental NDA includes clinical safety and efficacy studies, some of which were conducted more than 20 years ago.

WCC pointed out that although the studies may not directly address OTC use of emergency contraception, the safety and efficacy data include participants' tendency toward repeat use of the drug. Although Plan B would not be indicated for repeat use, WCC acknowledged consumers often take drugs for off-label uses.

The potential for a switch approval could be complicated by the broader debate over abortion; FDA received scrutiny for approving the abortifacient RU-486 (mifepristone, marketed by Danco as Mifeprex ) in 2000. FDA's approval of the drug is widely viewed as the reason that former Commissioner Jane Henney was not asked to stay on in the Bush Administration.

If a switch is approved, FDA can use one of several ongoing state programs as a model for the nationwide implementation of OTC emergency contraception. California, Washington state and Alaska already have collaborative practice agreements that allow pharmacists to dispense Plan B with physician authorization.

New Mexico is the most recent state to carry out such a program, although under its version Plan B will be pharmacist-prescribed and will not require physician intervention.

Legislation for the program was introduced almost two years ago in New Mexico; within six months, the Board of Pharmacy began working on the guidelines. The protocol has been approved by the state's Board of Nursing and now awaits approval from the Board of Medical Examiners, which is expected to occur at a meeting in mid-May.

Training for the pharmacists occurs in two parts - the first outlines information pharmacists must know about disease interactions, while the second involves lessons on recordkeeping and paperwork.

New Mexico's Department of Health said more than 100 pharmacists have completed the first set of training requirements, and nearly 50 have completed the second. Another 100 pharmacists are expected to undergo training in June.

WCC also noted legislation is "moving" in Texas and New York to facilitate distribution of emergency contraception, and efforts to introduce legislation are underway in Florida. Tennessee and Minnesota are looking to implement such programs without state legislation, according to WCC.

Regarding its switch application, WCC noted FDA typically responds to such submissions in 10 months. A joint Nonprescription Drugs Advisory Committee and Advisory Committee for Reproductive Health Drugs meeting on the switch likely will be held in six to eight months, the firm added.

FDA has tentatively set meeting dates for NDAC on Sept. 16-17, while the Reproductive Health committee is slated to convene on Aug. 18-19 and Nov. 13-14.