Primary dysmenorrhea is defined as painful menstruation in women. Credit: Vulvani / commons.wikimedia.org.

Daré Bioscience has commenced a Phase I clinical trial of its development programme to treat primary dysmenorrhea by delivering diclofenac, an active pharmaceutical ingredient, in a new method.

Daré Bioscience’s investigational product, DARE-PDM1, will deliver the nonsteroidal anti-inflammatory drug (NSAID) diclofenac vaginally through the company’s hydrogel.

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DARE-PDM1 is expected to have the potential to be a first-in-category product, delivering the NSAID in a convenient vaginal format.

This could prolong the pain relief duration and reduce the risks that are associated with the oral delivery of NSAIDs.

DARE Bioscience Australia, the company’s subsidiary, will conduct the DARE-PDM1 Phase I trial, DARE-PDM1-001, in the country.

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The randomised, multi-centre, placebo-controlled, double-blind, three arm, parallel group trial will be carried out in nearly 36 healthy, premenopausal women with primary dysmenorrhea.

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It will evaluate the systemic (plasma) and local mucosal (vaginal fluid) diclofenac pharmacokinetics (PK) and safety following a single dose and during three doses a day of DARE-PDM1 administered vaginally, versus a placebo.

It will be given in two different strengths.

Additionally, the study will evaluate the preliminary dysmenorrhea treatment efficacy of DARE-PDM1, as an exploratory endpoint, when given in three doses a day at the start of dysmenorrhea symptoms, against a no-treatment, baseline, control cycle.

The observation period of the study will cover approximately three menstrual cycles.

Daré Bioscience medical director Dr Annie Thurman said: “Local drug delivery through the vaginal mucosa allows lower doses that specifically target local genital tissues and the myometrium.

“By leveraging a vaginal route of administration, we believe we can provide a treatment option that addresses the pain-related symptoms of the condition while minimising side effects commonly seen with use of oral medications.”

Once the development programme is successful, Daré intends to leverage diclofenac’s existing safety and efficacy data to use the US Food and Drug Administration’s (FDA) 505(b)(2) pathway for securing marketing approval of DARE-PDM1 in the country.

Primary dysmenorrhea, which is defined as painful menstruation in women, usually starts during adolescence.