Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Hi JJ. Who can predict the FDA?

I've touched on this before, whereas I compared the FDA to a bouncer at a college bar and ADF is your I.D. to get in. Fake ID's are fine, but you must show something to get in. I also assert that the FDA will not hand over a monopoly to a single company, and so there will need to be multiple viable ADF's before non-ADF's will be pulled.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=113499564



I do not think ELI-200 is going to be the test case, since there is no other true ADF OxyIR. Oxaydo (nee Oxecta) has "abuse-deterrent properties" but did poorly in HAL studies and was never given ADF labeling. Along with Oxecta's 20X price premium over generic, it was never a true or viable ADF.

I think the better test case is going to be Zohydro. When approved in 2014, it had no abuse deterrent properties, and FDA took a lot of flack from every direction. Their reasoning never made sense:

http://www.fiercepharma.com/story/under-fire-fda-chief-hamburg-defends-approval-pain-pill-zohydro/2014-03-14

"We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy," Hamburg said.

...

"It doesn't do any good to label something as abuse deterrent if it isn't actually abuse deterrent, and right now, unfortunately, the technology is poor," Hamburg said.

In the midst of all the controversy, Purdue Pharma--the company that originally developed and sold the highly abused pain pill OxyContin--said it has finished a Phase III trial of its extended-release formulation of hydrocodone bitartrate, and that indeed it is abuse-deterrent.

The FDA repeatedly defended the decision because there was no other extended-release hydrocodone, no other hydrocodone at all that did not contain acetaminophen. They said Zohydro provided "options" and that they reserved the right to pull it when other ADF options became available. But the whole time they were taking fire, Purdue was right around the corner with Hyslinga, which did fairly well in HAL studies. It was approved less than 1 year later with ADF labeling. Likewise Teva has an extended release hydrocodone with ADF that will be filed this year. And, I hope, Elite, if it chooses, could have an extended release ADF hydrocodone within 1-2 years.

On its own, Zogenix reformulated Zohydro to have abuse deterrent properties. I discussed Zohydro with BeadTek here:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=115503585

After further investigation, I have determined that not only has there been no published HAL study, but also no HAL data has ever been presented to FDA. Therefore, Zohydro does not currently carry ADF labeling. The package insert clearly suggests there are issues:

Taking cut, broken, chewed, crushed, or dissolved ZOHYDRO ER enhances drug release and increases the risk of overdose and death. With intravenous abuse, the inactive ingredients in ZOHYDRO ER can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury.

I think given the previous heat on the FDA, Zohydro is going to be the test case. Hyslingla ADF is approved. TEVA's is near. Hopefully, Elite's ADF hydrocodone soon to follow. Unless Zohydro comes up with some pretty impressive HAL data, I think its days are numbered. And if FDA allows Zohydro to remain while 2-3 other true hydrocodone ADF's are available, then we'll all know FDA was full of sh## to begin with.




As for your other point:

There is a legal issue here where if one has access to an ADF opioid and chooses not to prescribe it going with the non-ADF
instead one runs the risk of liability should something happen to the patient by abusing the non-ADF he/she prescribed.

When it comes to non-generic drugs, my choices are limited by insurance coverage. Not a big issue for me, as I Rx ~98% generics, but my preference is essentially moot, unless a patient is willing to pay 100% out of pocket for a nonformulary branded drug. Couch and others have detailed the legislative and community activist efforts to force Medicare and private insurances to cover ADF drugs, but as of now, it's kind of hard to hold docs responsible for not prescribing ADF's when the insurance companies refuse to pay for them.