Vyleesi · Female hypoactive sexual desire disorder
Development and Regulatory status
Jun 19. Approved in US with launch expected Sept 2019 [10,11]
Mar 18: Filed in the US for treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. If approved, bremelanotide would become the first and only as desired pharmacologic option in the U.S. indicated for the treatment of HSDD in premenopausal women .
Dec 17: Palatin has previously received comprehensive guidance from the EMA on PIII development in Europe .
Nov 17: AMAG Pharmaceuticals intends to file in US Q1 18 .
Nov 16: New Drug Application to the FDA is targeted for the second half of 2017 .
Sep 15: Richter backed out of the collaboration with Palatin because the EMA required such further trials that the company chose not to undertake for risk and cost factors. Palatin is moving forward with two PIII studies on bremelanotide involving about 1,100 women, & expects to have top-line results in Q3 2016. Palatin is actively engaged in licensing and collaboration discussions with multiple companies for global and regional rights to bremelanotide .
Sep 15: Gedeon Richter dissolves the partnership with Palatin Technologies, and returns all rights to bremelanotide to Palatin .
In September 2014, Palatin entered into a collaboration and licensing agreement with Gedeon Richter for the co-development and commercialisation of bremelanotide for the treatment of female sexual dysfunction in the European Union, other European countries and certain additional countries. Under the terms of the agreement, both companies will be responsible for the European development activities, including a phase III study, aimed at obtaining regulatory approval in Europe. Sept 14 (ADIS)
Studies with intranasal formulation discontinued. PII study with subcutaneous injection started Aug 09 .
Discontinued for female sexual arousal disorder, May 08 (2)
PIIb trials to commence (1).
Trial or other data
Nov 16: Co-primary endpoints met in two PIII studies (n=1202) Reconnect-301 (NCT02333071) and Reconnect-302 (NCT02338960). Bremelanotide showed a statistically significant increase in the Female Sexual Function Index: Desire Domain vs. placebo; and a statistically significant reduction in distress related to low sexual desire in both trials (p<0.006 for all) .
Feb 14: New data from phase 2b trials. More women treated with bremelanotide 1.75mg had an improved Female Sexual Function Index (FSFI) total scores were significantly than with placebo: 69% vs. 46%. A significantly more women on bremelanotide 1.75mg vs placebo achieved at least one satisfying sexual event (SSE): 55% vs. 37%. Female Sexual Encounter Profile – Revised (FSEP-R), demonstrated greater mean increases in SSEs within 24 hours of dosing with bremelanotide 1.75 mg vs. placebo, mean increases 0.7 vs. 0.1, p=0.0443. As-needed administration of bremelanotide 1.75 mg vs. placebo demonstrated episodic increases in levels of desire (0.4 vs. 0.0) and in the women´s satisfaction with their levels of desire (0.6 vs. 0.1). Women´s Inventory of Treatment Satisfaction (WITS-9) showed women who completed treatment were significantly more satisfied with bremelanotide 1.75 mg (0.77; p=0.0204) versus placebo (0.17). 
Nov 12: Positive top-line results reported of PIIB clinical trial evaluating the efficacy and safety of bremelanotide for the treatment of female sexual dysfunction (FSD). The trial was a multi-centered, placebo-controlled, parallel-group dose-ranging RCT designed to evaluate the safety and efficacy of three subcutaneous (SC) bremelanotide fixed doses of 0.75, 1.25, or 1.75 milligrams intended for on-demand use in premenopausal females with FSD. The primary endpoint data analysis of 327 pre-menopausal women with female sexual arousal disorder (FSAD), hypoactive sexual desire disorder (HSDD), or a combination of both disorders, the most common types of FSD, shows a clinically meaningful and statistically significant improvement (p=0.018) in the number of SSEs in women taking bremelanotide doses (mean change from 1.6 at baseline increasing to 2.4; pooled 1.25 mg and 1.75 mg doses) versus placebo (mean change from 1.7 at baseline increasing to 1.9) over the study period, resulting in a 50% increase in SSEs with bremelanotide versus 12% with placebo. Key secondary endpoints showed clinically meaningful and statistically significant improvement in pts who received bremelanotide vs. placebo (mean change from baseline to end of study; pooled 1.25 mg and 1.75 mg bremelanotide doses): Female Sexual Function Index (FSFI) total score improvement (mean change of 3.55 vs. 1.88, p=0.0017). Reduction in distress related to sexual dysfunction, as measured by the Female Sexual Distress Scale-DAO (FSDS-DAO), 15-item questionnaire is designed to assess and quantify the change in personal distress associated with female sexual dysfunction, total score improvement (mean change of -11.1 vs. -6.8, p=0.036). The most common types of treatment-emergent adverse events reported more frequently in the bremelanotide arms were facial flushing, nausea and emesis, which were mainly mild-to-moderate in severity. The study dosed 395 pts. A total of 26 pts discontinued from the study based on predefined blood pressure criteria: these pts were evenly distributed across the placebo and bremelanotide dosing arms. An additional 12 pts discontinued from the study due to adverse events (N=12, Placebo: 2, bremelanotide arms 0.75 mg: 0, 1.25 mg: 4, 1.75 mg: 6). Adverse events that most commonly led to discontinuation were nausea and emesis .
The primary endpoint of PIIb study is to evaluate the safety and efficacy of PT 141 in FSAD patients in the at-home environment (1).