Letter to be sent to editors, etc. I have updated the letter posted by goodh2o1 to be sent to editors and/or elected representatives, and others in government. If anyone can improve on my version, please do so and post it. Here is my updated version:
Dear Editor….
I have been following a company called Elite Pharma (ELTP) which has a patent on an opioid medication called “Sequest-Ox” that reduces the possibility of abusing opioids. Elite accomplishes this goal by coating the opioids with Narcan.
Taken properly, the Narcan passes through and has no effect. However, if the pill is crushed to snort or inject, you get only the Narcan.
Elite went to the FDA in 2014, stated the tests they had run successfully and asked if anything further was needed. They were told that no further tests were needed. ELTP then received a waiver of NDA application fee as well as priority review, yet their application was not approved in July of this year.
The reason cited is that there is a chance for someone to overdose if they take the medication with a fatty meal, because the pain-relieving effect is delayed and the person might therefore take an additional dose. However, all currently approved immediate release opioids (none of which are abuse deterrent) have the exact same "fatty meal” problem. Simple labelling directions to take the medication either one hour before a meal or two hours afterwards were deemed sufficient for those other opioids to be approved and should likewise be sufficient for approval of Elite’s "Sequest-Ox”.
Elite’s cutting edge technology is applicable to 17 different opioids and needs to go forward! As is well-known, there is an epidemic of deaths by opioid abuse in this country and Elite’s technology would provide a powerful new way to significantly mitigate this enormous problem. Politics of any kind should not be allowed to hold back "Sequest-Ox”!
