Policy responses and statements
- Name of organisation:
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Name of policy document:
- ARM 53: Request to Reclassify a Product from P to GSL - Nicorette 25mg Patch
- Deadline for response:
- 7 May 2008
Background: A new higher strength nicotine containing patch is proposed for GSL availability releasing 25mg over 16 hours. Clinical studies have demonstrated that a higher strength 25mg 16 hour patch is significantly more effective in achieving smoking abstinence than a 15mg patch regimen.
COMMENTS ON
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)
ARM 53: REQUEST TO RECLASSIFY A PRODUCT FROM P TO GSL - NICORETTE 25MG PATCH
The Royal College of Physicians of Edinburgh is pleased to respond to the MHRA on consultation ARM 53.
The proposal is for Nicorette 25mg patches to be reclassified from P to GSL. Nicorette 15mg patches are already classified for use as GSL without apparent problems either from a use or adverse effect problem.
Clinical studies have demonstrated that the higher strength 25mg 16 hour patch is significantly more effective in achieving smoking abstinence than the 15mg patch. In addition, large clinical studies have shown that the safety profiles of the 25 and 15mg patches are similar, the only difference being an increase in nausea/vomiting with the 25mg patch. However, the Patient Information Leaflet deals with this potential problem by encouraging lighter smokers to start with the 15mg patch and those who experience nausea or vomiting with the 25mg patch to use the 15mg patch instead for the remainder of the 8 week course.
The potential role of healthcare professionals is also emphasised, with the advice that the products are most likely to be successful when used with help from pharmacist, doctor, trained counsellor, or a support programme.
It would appear to the College that a strong case has been made for this reclassification and that there are no significant safety issues. The College therefore supports this proposal.
Copies of this response are available from:
Lesley Lockhart,
Royal College of Physicians of Edinburgh,
9 Queen Street,
Edinburgh,
EH2 1JQ.
Tel: 0131 225 7324 ext 608
Fax: 0131 220 3939
[25 April 2008] |
