Date: 2017-02-27
Type of
information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the International Society for the Study of Women’s Sexual Health Annual Meeting
Company: Amag Pharmaceuticals (USA - MA) Palatin Technologies (USA - NJ)
Product: Rekynda™ (bremelanotide)
Action
mechanism: peptide/melanocortin agonist. Bremelanotide is a melanocortin agonist drug candidate. This synthetic peptide is an analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). It is thought to possess a novel mechanism of action, activating endogenous melanocortin pathways involved in sexual desire and response.
Disease: pre-menopausal women diagnosed with hypoactive sexual desire disorder (HSDD)
Therapeutic
area: Women health
Country: USA
Trial
details: This randomized open label parallel study is designed to demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®. (NCT02940522)
The randomized open label parallel study is designed to compare the average injection pain of four weekly injections between the subcutaneous and intramuscular injections of Makena® using a validated pain scale. (NCT02937766)
Latest
news:
- On February 27, 2017, Amag Pharmaceuticals, together with Palatin Technologies, announced that additional results from the Phase 3 RECONNECT Studies (301, 302) of Rekynda™ (bremelanotide) were presented at the International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting in Atlanta, Ga. Rekynda is an investigational product being developed as a potential on-demand treatment for pre-menopausal women diagnosed with hypoactive sexual desire disorder (HSDD).
- Both Phase 3 studies met their co-primary endpoints of improvements in desire (as measured by the Female Sexual Function Index – Desire domain (FSFI-D)) and decrease in associated distress (as measured by the Female Sexual Distress Scale – Desire/Arousal/Orgasm (FSDS-DAO)). These results were previously reported in November 2016 by Palatin Technologies who sponsored the studies prior to entering into a licensing agreement with AMAG for the North American rights to Rekynda™. The statistically significant changes to FSFI-D and FSDA-DAO presented at the ISSWSH Annual Meeting met the pre-specified threshold for achieving clinically important differences for both desire and distress in women treated with Rekynda™.
- Multiple secondary endpoints were evaluated as part of the Phase 3 RECONNECT studies to provide a more comprehensive picture of Rekynda™’s effect on different aspects and symptoms of sexual dysfunction. Rekynda™ was associated with statistically significant improvements in the total FSFI score including arousal, lubrication, orgasm, and satisfaction domain scores (all p?0.01). Scores for satisfaction with desire and arousal on the Female Sexual Encounter Profile-Revised showed statistically significant improvement from baseline in Study 301 (p?0.01) but did not reach statistical significance in Study 302.7 Changes in the number of satisfying sexual events (SSEs) showed some improvement but were not significantly different in either study.
The most frequent adverse events with Rekynda™ in both Phase 2 and Phase 3 clinical trials were nausea, flushing, and headache. These effects were generally mild-to-moderate in severity. Approximately 18 percent of patients in the Rekynda™ arm of the Phase 3 trials discontinued participation due to adverse effects. Rekynda™ has no known alcohol interactions.
Is
general: Yes
