Mercy,
The REMS requirements are statutory per FDAAA. How to meet is better described in the FDA guidance in 2009 here at
http://wp.me/P4xpOK-o8 As for "Is there REMS requirement for the same drug if developed for new route of administration by intra-oral route?," it would depend on whether FDA sees there may be new and potentially serious risk issues.
In view of the following information, it is somewhat borderline issue.
Respiratory problems.
You have a higher risk of death and coma if you take SUBOXONE with other medicines, such as benzodiazepines. Also benzodiazepines may increase respiratory depression.
Do you recommend voluntarily asking FDA any question related to REMS or wait for FDA to comment on it?
I would recommend you please sit back, relax and wait for FDA to tell you REMS is required as FDA is given the authority by the FDAAA to request the REMS before and after drug approvals.
Is there a need to contact the FDA controlled substance staff or any other action required with new dosage form of a already approved Schedule-IV drug?
Unless you voluntarily want to, I would recommend you wait for the FDA to tell you whether the REMS is required.
But since you are planning on an IND study, you may have planned on having a meeting with the FDA.
Early in the process when you meet with the FDA, you can try to state that "it is not believed that the REMS may be required as no new or potentially serious patient safety issues have been identified."
When you do so, let's see what they say!
____________________________________________________________ Dr. David Lim, Ph.D., RAC, ASQ-CQA "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor
Original Message:
Sent: 05-13-2015 14:03
From: Mercy James
Subject: REMS requirement for a new dosage form
Dear Friends,
I have a question regarding REMS requirement for a new dosage form. The molecule is a Schedule-IV benzodiazepine class drug with CNS effect which was approved by FDA before the REMS times. Currently there is no REMS existing for the approved enteral and other dosage forms. Just that the adverse reaction section provides statements on drug dependence, abuse potential etc. Is there REMS requirement for the same drug if developed for new route of administration by intra-oral route. Do you recommend voluntarily asking FDA any question related to REMS or wait for FDA to comment on it. Is there a need to contact the FDA controlled substance staff or any other action required with new dosage form of a already approved Schedule-IV drug? Currently planning for an IND study.
Thanks in advance for your valuable responses and recommendations.
Best regards,
Mercy
-------------------------------------------
Mercy James PHD, RAC, SCD
Warren NJ
United States
-------------------------------------------