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abstract

abstract

008

Bremelanotide provides meaningful treatment benefits for premenopausal women with hypoactive sexual desire disorder

Koochaki, PE1; Revicki, DA2; Wilson, H3; Pokrzywinski, R2; Jordan, R4Lucas, J4

1: PEK Market Research, Inc, United States; 2: Evidera, Bethesda, MD, United States ; 3: Evidera, Seattle, WA, United States ; 4: Palatin Technologies, Inc., United States

Objective: Assess treatment benefit and meaningfulness of treatment among a subset of premenopausal women participating in the 2 Phase 3 RECONNECT studies of bremelanotide (BMT).

Material/Methods: Participants were randomized to self-administer BMT (1.75 mg) or placebo subcutaneously via an auto-injector pen, as desired, prior to sexual activity for 24 weeks. At study completion, volunteers participated in an Exit study developed using a mixed-method design. A quantitative survey was used to assess meaningfulness of treatment benefits, whether expectations for treatment were met, and satisfaction with the auto-injector device. Qualitative interviews were used to understand patients’ experiences and impact of treatment, explore why treatment was meaningful, learn whether expectations for therapy were met, and understand their experiences with the injection device.

Results: 242 women completed the quantitative survey, including 80 who participated in the qualitative interviews. Participants were mean age 38.9 years; 98.3% had a male partner; 62.4% were diagnosed with HSDD with decreased arousal (mean duration of HSDD diagnosis: 55.2 months). 58.8% of women in the BMT group reported overall meaningful benefit vs 27.1% in the placebo group (P<0.0001). Compared with placebo, significantly more women in the BMT group reported a meaningful increase in sexual desire (51.0% vs 20.7%) and responsiveness to their partners initiating sexual activity (53.9% vs 25.7%; P<0.0001 for both). Significantly (P<0.0001) more women on BMT also experienced a meaningful decrease in their concern over low sexual desire (49.0% vs 19.3%). Overall, 62.4% of participants rated their experience with the device as excellent or very good. The most common reason for enrolling in the trial was to increase sexual desire, highlighting its importance at diagnosis and as a primary endpoint in clinical trials.

Conclusions: Women randomized to bremelanotide consistently reported meaningful treatment benefits compared with placebo. These data support the primary efficacy results in the RECONNECT studies in which women using bremelanotide had significantly increased scores on the Female Sexual Function Index indicating an increase in desire and a significant reduction in their Item 13 score on the Female Sexual Distress Scale-Desire/Arousal/Orgasm scale indicating a reduction in distress due to low sexual desire (both P≤0.01).

Disclosure:

Work supported by industry: yes, by Palatin Technologies, Inc. (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.

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