FDA approval of cream to treat bacterial vaginosis

Dec 3 2004

KV Pharmaceutical Company has announced that it has received approval from the United States Food and Drug Administration (FDA) to market Clindesse (clindamycin phosphate) Vaginal Cream, 2%, a single-dose prescription cream therapy indicated to treat bacterial vaginosis ("BV").

Clindesse, which utilizes KV's proprietary VagiSite bioadhesive drug delivery technology, is the first approved single-dose therapy for patients with bacterial vaginosis the most common form of vaginitis. The one- dose product was demonstrated in clinical trials to effectively treat BV and its symptoms with results equivalent to 7 days of Cleocin(R) vaginal cream. Currently, other approved BV treatments require a course of 3-10 doses.

"Clindesse is a significant innovation for patients with BV," said Marc S. Hermelin, Vice Chairman and CEO of KV. "As the only single-dose therapy approved for convenient and effective treatment of BV, we believe Clindesse's convenience will be compelling to both physicians and their patients. In clinical trials supporting the product's approval, more than 95% of patients taking Clindesse complied with the treatment regimen, as compared with 65% compliance with the 7-day prescription cream comparator. The arrival of Clindesse further underscores our Ther-Rx subsidiary's growing prominence in the important vaginal anti-infective therapeutic segment of the women's health market. Ther-Rx anticipates the launch of Clindesse in January 2005."

Bacterial vaginosis, is believed to represent nearly half of all vulvovaginal infections. In fact, the intravaginal BV product segment alone has an estimated U.S. market size of $138 million for the twelve months ending October 2004, according to IMS NSP. Accurate diagnosis of BV by a physician can be difficult, as more than 50% of patients may be asymptomatic. Additionally, it is widely believed that patients may inaccurately self- diagnose, and therefore, improperly treat BV and other vaginal infections. Numerous articles in peer-reviewed journals cite the association of BV with other conditions, including pelvic inflammatory disease, pre-term labor, and a number of other gynecologic and obstetric complications. Clindesse offers a new and convenient treatment option for BV.

The FDA's approval of Clindesse marks KV's first NDA approval stemming from the Company's previously reported ramp-up in branded drug research activity.

Clindesse is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream, and in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.

Clindesse contains mineral oil that may weaken latex or rubber products such as condoms or contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin. Orally and parenterally administered clindamycin has been associated with severe colitis. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of Clindesse, even though there is minimal systemic absorption of clindamycin from the vagina with administration of Clindesse Vaginal Cream.

In clinical trials (n=368), the most frequent reported adverse events were vaginosis fungal (14.1%), vulvovaginal pruritus (3.3%), and headache (2.7%).