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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.