This article was originally published in Pharmaceutical Approvals Monthly
Urologics Subcommittee of FDA's Reproductive Health Drugs Advisory Committee recommends approval of TAP's Uprima (apomorphine) April 10 based on six Phase III studies in 2,103 patients with erectile dysfunction (ED). The subcommittee unanimously recommended the 2 mg dose, which showed a 44% to 47% success rate for the primary endpoint - the percentage of attempts resulting in an erection firm enough for intercourse - compared to 32-38% for placebo. The subcommittee voted nine to three to recommend the 4 mg dose, which showed a success rate of 52-56% vs. 31-35% for placebo. Safety of the higher dose was a concern for the committee, which noted that there was limited testing among diabetics. The committee recommended a boxed warning against the use of alcohol and nitrates. Four studies showed greater drops in blood pressure for subjects using Uprima with alcohol, and adverse reactions were seen in 25 to 30% of subjects when the drug was paired with nitrates. In addition, the committee recommended that labeling reflect the fact that the Uprima trials excluded patients suffering from complete ED (those who did not have a normal nocturnal penile tumescence)
You may also be interested in...
The Canadian authorities have put in place an expedited pathway for authorizing new COVID-19 drugs and vaccines that offers a more agile approach to reviewing data than what was previously allowed.
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
No device-related warning letters were released by the US FDA the week of 22 September.