Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

This is not evidence-based medicine.

So it is that, what Weezhul suggests can offer a simple fix to the problem…or an Occam’s Razor. Remember, the simplest explanation is often the best. So it is with fixing problems. I am no scientist or medical expert, but I recognize from basic statistics that to reformulate is asking for a totally new trial. Simple is best and Eugene is the guy to make the argument. Here is Weezhul’s Occam’s Razor (also known as the Law of Parsimony)…that we should hope is the basis for Eugene's argument to the FDA that is well established and often appears on prescription labels in one form or another...

SequestOx should be taken on an empty stomach. Taking less than 2 hours after eating may delay the effect. NEVER TAKE MORE THAN ONE PILL IN FOUR HOURS

I cannot find a single reference or even a single anecdotal report of a patient injury due to opioid overdose caused by taking too much medicine because of a delayed effect due to nonfasting status. The entire concept that the delayed Tmax with fatty meals may contrtibute to an overdose is PURE THEORY, and I cannot find even a single case report. The below article is a very recent, very thorough review of unintentional opioid overdoses. Hundreds of studies were reviewed. Many risk factors were identified-- NONE of them had to do with fasting vs. fed status of patients. Many of the risks were associated with abusive or aberrant behavior. There is simply no medical evidence that I can find that supports the FDA's argument here. I will await to hear what the actual Tmax delay is and what the parties come up with when they meet. Depending on those important details, the next step would have to be a coordinated campaign to bring these actions of the FDA to the attention of newspapers and congress-critters. Public pressure on the FDA has been successful in the past. They need to be convinced by whatever allies we can muster that the quality of the ADF tech for both SequestOx and Avridi is unassailable, and the so-called "safety" concerns are purely theoretical and not supported by the scientific literature. As others have suggested, the question can be boiled to this: just how interested is FDA in preventing abuse of prescription opioids?





http://www.painphysicianjournal.com/current/pdf?article=MjcwNA%3D%3D&journal=96

Patient Characteristics and Outcomes in
Unintentional, Non-fatal Prescription Opioid
Overdoses: A Systematic Review
Pain Physician 2016; 19:215-228 • ISSN 1533-3159

Conclusion
Opioid overdose morbidity is significantly more
prevalent than mortality, and sequelae of toxic events
should be studied in more detail. Increased risk of morbidity
occurs with: (i) increased opioid availability in
the community, (ii) increased dosage, (iii) use of methadone,
(iv) nonmedical use, dependence, and illicit drug
use, (v) aberrant behaviors, (vi) past suicide attempt,
(vii) decreased or lower tolerance, (viii) lack of education,
(ix) middle age, (x) poverty, (xi) presence of mental
health disorders, (xii) medical comorbidities, and (xiii)
co-ingestants. Although abuse-deterrent formulations
have been approved, there is no overdose-safe prescription
opioid available to date. Opioid overdose morbidity
and mortality is seen across the entire spectrum of
patient use with significant numbers of adverse events
occurring in population segments not identified by
high risk indicators. Increased physician awareness of
this epidemic as well as additional education on lifethreatening
opioid-induced respiratory depression that
can occur in any patient using opioids as opposed to
patients suspected of suffering from an opioid use disorder,
as well as the availability of take-home naloxone
could help mitigate the overdose epidemic while maintaining
effective pain control for patients.