Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

TAP Uprima

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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...



New Canadian Rule Allows Rolling Data Submissions For COVID-19 Drugs, Vaccines

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.

‘No Turning Back’ On Regulatory Changes at UK MHRA

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.

Warning Letter Roundup & Recap – 22 September 2020

No device-related warning letters were released by the US FDA the week of 22 September.

Topics

UsernamePublicRestriction

Register

ID1122310

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel