HBW Insight 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

GSK’s Proposal For Mouth Spray Nicorette Delayed By FDA Questions On Label

Executive Summary

Glaxo plans to make changes FDA requested in Complete Response letter sent on 18 October, the agency’s deadline for acting on NDA for an oral spray that delivers 1 mg per spray of aqueous buffered nicotine solution for oromucosal use.

You may also be interested in...



NDAC Recommendation To Approve GSK's Mouth Spray NRT Comes With Caveats

No more than three votes decided the panel's recommendation on each FDA question, and members in the prevailing majorities explained they made their votes with reservations. Potential use by young consumers and confusion by adult users in following the label instructions were primary concerns for all panel members.

'Naturalistic' Trial In GSK's Nicotine Mouth Spray NDA Historic For OTC NRTs

What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.

GSK Proposal For Novel Delivery NRT Leaves FDA Doubting 'Real World' Efficacy

In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS149584

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