Palatin Technologies Inc. (PTN)

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http://www.palatin.com.ws054.alentus.com/assets/whe-2016-0018_Clayton.pdf


• Female sexual dysfunction is a common and distressing condition with limited treatment options currently
available.
• A total of 397 women were randomized to receive placebo or bremelanotide (BMT) 0.75, 1.25 or 1.75 mg over
12 weeks. Efficacy data were available for 327 women.
• Women with female sexual dysfunction treated with 1.25/1.75 mg BMT showed a statistically significant
increase in the number of satisfying sexual events/month compared with patients treated with placebo. BMT
0.75 mg did not differ from placebo.
• Significant increases were also observed in female sexual function index total score and female sexual distress
scale-desire/arousal/orgasm total score.
• Women with a primary or sole diagnosis of hypoactive sexual desire disorder showed responses to BMT similar
to those in the full study population
• The most common treatment-emergent adverse events were nausea, flushing and headache, with no marked
dosage dependence.

In premenopausal women with HSDD, FSAD or
both conditions, double-blind BMT self-administered
subcutaneously on an at-home, as-desired basis over
12 weeks showed significant efficacy versus placebo,
as demonstrated by an increase in the monthly number
of SSEs (the study’s primary outcome measure)
and by multiple other measures, both episodic and
longer-term (longitudinal), with robust consistency.

The findings of this large Phase IIB trial provide further evidence
of the safety and efficacy of BMT in premenopausal
patients with FSAD and/or HSDD, and suggest that
ongoing Phase III registration trials may confirm BMT
as a significant as-desired treatment in this important,
underserved patient population.