Palatin Technologies Inc. (PTN)

[seasonedwell]

Addyi (flibanserin) is anticipated to struggle in achieving favorable insurance coverage, and the inconvenience of daily dosing combined with the side effect profile will significantly restrict its sales.
Bremelanotide was equally effective in increasing the number of satisfying sexual events in Phase II clinical trials, and the take-as-needed dosing of bremelanotide would be an advantage in competing against Addyi.
If bremelanotide can hold up in Phase III clinical trials, it has the potential to equal or surpass Addyi’s sales.

Results from a Phase II clinical trial on bremelanotide are already available, and when compared to placebo this drug results in the same increase in the number of satisfying sexual events as Addyi achieved in Phase III trials. Bremelanotide is a subcutaneous formulation, and women would self-administer the drug as they desire, rather than adhering to the strict dosing schedule required by Addyi; this could be a major advantage in the marketplace, especially as it would be easier to avoid the negative side effects noted for both drugs. Addyi’s side effect profile includes nausea, fatigue, headache, dizziness, and sleepiness, with up to 75% of patients in trials reporting at least one adverse effect. Additionally, the FDA required a black box warning that prohibits using alcohol while taking Addyi, a major challenge for patients taking a daily lifestyle drug. While the number of patients suffering from side effects is marginally lower (68% in the high dosing group) for bremelanotide, it has an arguably worse side effect profile which includes vomiting, diarrhea, abdominal pain, and ironically breast tenderness and genital discomfort, likely negating the libido-enhancing impact of the drug in those who experience these particular consequences.