Plan B Emergency Contraceptive Switch NDA Planned

Women's Capital Corporation will file an NDA next year to switch its Plan B emergency contraceptive to OTC status, the company said Dec. 13.

Protocols are being designed with the non-profit Family Health International for label comprehension and actual use studies, the firm stated.

Actual use data from a two-year-old pilot program in Washington that made ECs available directly through pharmacies following a consultation with a pharmacist will be included, WCC noted (¹ (Also see "OTC Emergency Contraceptive Restricted Access Supported By Gynetics Exec" - Pink Sheet, 10 Jul, 2000.)).

The company's actual use study findings additionally will be bolstered by data being gathered through EC pilot programs launching in California, Alaska and British Columbia, WCC said.

Information on the availability of ECs sold over-the-counter and behind-the-counter in foreign markets also will be used to support Plan B's OTC status in the U.S.

The company asserted it will be able to draft labeling adequate to communicate the uses and risks of its progestin-only EC, but added that if approved OTC, pharmacies likely would place the product on or behind counters to prevent sale to minors. Such a practice frequently has been used with smoking cessation products.

WCC also said it is working with the American Pharmaceutical Association to develop a training program to assist pharmacists in dealing with women requesting emergency contraceptives. The program will provide advice not only on counseling patients but also on when to refer a patient to a doctor or clinic, WCC stated.

The American Medical Association recently adopted a policy statement saying if FDA found ECs to be safe and effective in an OTC setting, it would support the agency's decision (² (Also see "AMA "Support" For Emergency Contraceptive Switch Applications Voiced" - Pink Sheet, 11 Dec, 2000.)).

Currently, Gynetics' Preven (estrogen and progestin) is the only other dedicated EC available in the U.S. The firm plans to launch a progestin-only product but said it will consider filing an OTC switch application only when that product is approved for Rx use.

Gynetics previously has spoken out in support of OTC access for ECs with restrictions, including withholding the products from minors and establishing a behind-the-counter system for the class.

Both Plan B and Preven have been floated as OTC switch candidates in the past, but both companies have considered their lack of financial resources as an impediment to supporting a successful NDA and consumer launch (³ (Also see "OTC Emergency Contraceptive TV Ad Support Necessary For Switch" - Pink Sheet, 27 Nov, 2000.)).

Neither firm has had success in partnering with a major drug company, but WCC said it hopes to secure such backing if its NDA is approved.

Meanwhile, a drug with the same formulation as Plan B has been approved for behind-the-counter sale in the U.K. Schering Health Care's progestin-only Levonelle was approved for "pharmacy" status by the Medicines Control Agency Dec. 10.

ECs have become available without a prescription in other countries as well. HRA Pharma's progestin-only NorLevo (also known as Vikela in certain markets) has been sold behind-the-counter in France since late May 1999. The same EC launched OTC in Norway and behind-the-counter in Portugal in October, is launching in South Africa now and will be available in Belgium and Sweden early next year.

Levonelle, the first nonprescription EC to be permitted in Britain, should be available by the end of January or early February, the Schering AG subsidiary noted. MCA's action does not take force until a parliamentary consultation in the House of Commons is completed. The consultation began Dec. 11 and will take 21 days.

The drug contains levonorgestrel 750 mcg and was approved at the same dosage as Levonelle 2, the Rx version that launched in the U.K. in February. Schering, which does not sell the product in any other country, filed its switch application in May.

The only other EC on the British market is Schering's PC4, which contains progestin and estrogen. PC4 was considered inappropriate for pharmacy status because of its comparatively high potential for side effects. Both Schering ECs will remain available by prescription; the company estimated the products combine to sell roughly 1 mil. units per year.

A single course of Levonelle will retail for [L]19.99 (about $30) and will be available only after consulting with a pharmacist. Schering said the high cost of the drug is meant to discourage frequent use; the wholesale price is approximately [L]9.40 (about $14).

Moreover, the drug is intended for women 16 and older, may be given to third parties only under special circumstances and is not to be given out prior to unprotected intercourse as a precautionary measure. Pharmacists also may refuse to sell the EC due to moral or ethical concerns, but those who do so must refer women to alternate suppliers.

Similar to WCC's plans with APhA, the Royal Pharmaceutical Society (RPS) and the Pharmaceutical Society of Northern Ireland are developing a training program to prepare pharmacists for the role they will play in dispensing Levonelle.

Informational packets will be distributed to pharmacies across the U.K. and voluntary training sessions will be conducted. RPS published its guidelines for dispensing the drug on its Web site Dec. 16 and the program is set to run in time for the product launch. The training program will focus not on the drug itself but on how to counsel patients requesting it, RPS said.

The guidelines suggest pharmacists question consumers about other drugs or supplements they take, whether the unprotected intercourse occurred within the necessary 72-hour window and other issues related to the whether taking the EC is appropriate.

Pharmacists also must assess whether the consumer needs a physician's attention and make sure patients understand the risks and instructions for using Levonelle. RPS said most British pharmacies have a private area for consultations.

In addition, packaging for Levonelle will include an information packet and a phone number consumers can call 24 hours a day for advice and support.

The product will not be promoted via consumer advertising; instead, Schering will market the drug directly to health care professionals. The move is meant to address concerns that ECs could discourage contraceptive use in the general public.

RPS has lobbied for pharmacy status for ECs and predicted other products in the class would not have difficulty securing approval if they had safety and efficacy profiles similar to Levonelle. Other groups advocating nonprescription access to ECs in Britain have included the Proprietary Association of Great Britain, Birth Control Trust, Family Planning Authority and British Pregnancy Advisory Board.