FDA Gives ‘Priority Review’ to New Hydrocodone Painkiller

FDA Gives ‘Priority Review’ to New Hydrocodone Painkiller

The race to be the first drug maker to get approval for a hydrocodone painkiller with an abuse-deterrent formula continues to heat up.

Purdue Pharma says the Food and Drug Administration has given a priority review designation to the company’s hydrocodone bitartrate tablet, which is designed to make it harder for drug abusers to crush or liquefy for snorting or injecting. The FDA gives priority review to new drugs if they offer “significant improvements” in safety and effectiveness compared to existing medications.

Female Scientific Research Team With Clear Solution In LaboratorPurdue filed a new drug application for its hydrocodone painkiller in April and expects the FDA to make a decision in October.

That is the same month San Diego based Zogenix (NASDAQ: ZGNX) plans to file a new drug application for an abuse deterrent formulation of Zohydro ER, the controversial hydrocodone painkiller the company introduced without any tamper resistant properties.

In addition to Purdue and Zogenix, Pfizer (NYSE: PFE) and Teva Pharmaceuticals (NYSE: TEVA) are also developing “pure” hydrocodone painkillers with abuse deterrent properties.

Until the introduction of Zohydro, the only hydrocodone products on the market were combined with acetaminophen, which at high doses can cause liver damage. Hydrocodone combination drugs such as Vicodin, Lortab and Lorcet are the most commonly prescribed and abused painkillers in the U.S. with over 130 million prescriptions annually.

“It is imperative to provide healthcare professionals with an array of therapeutic options to ensure chronic pain patients receive individualized care,” said Todd Baumgartner, MD, Vice President of Regulatory Affairs and Chief Medical Officer at Purdue Pharma. “If approved by the FDA, this product will be a valuable therapy for treating chronic pain, and it is also designed to deter misuse and abuse by various routes of administration.”

Zogenix is developing two different abuse deterrent formulations for Zohydro ER. One would make Zohydro extended release capsules harder to crush or liquefy. The company hopes that formulation will be approved in early 2015.

Zogenix is also developing a Zohydro tablet in collaboration with Altus Formulation. The tablet would be extremely hard to make it difficult to crush and would also contain other properties to discourage drug abusers from injecting it. A new drug application for a Zohydro tablet isn’t expected until the first half of 2016.

“We believe we have two strong technology options to deter misuse and abuse without affecting the established safety and efficacy profile of Zohydro ER, and look forward to submitting our data to the FDA with the goal of bringing these new options to patients,” said Stephen Farr, President of Zogenix. “We also continue to take part in comprehensive and collaborative efforts with prescribers, pharmacists and government officials to help ensure appropriate patients have access to the medications that will best support the management of their severe chronic pain.”

A wave of controversy has surrounded Zohydro since its introduction in March. Some politicians and addiction treatment experts have claimed the painkiller will fuel a new wave of narcotic addiction because it does not come in an abuse-deterrent formula.

Massachusetts Gov. Deval Patrick tried to ban the prescribing of Zohydro in his state, a move that was blocked by a federal judge who ruled the governor was interfering with the authority of the FDA to regulate prescription drugs.

After his emergency order was ruled unconstitutional, Gov. Patrick then announced new restrictions on Zohydro that require doctors to evaluate a patient’s substance abuse history, provide a letter of medical necessity to pharmacies, and sign a pain management treatment agreement with all patients who are prescribed the drug.

Zogenix filed a federal lawsuit saying the new regulations are unconstitutional and impose “draconian” restrictions that “amount to an effective ban of the drug.” A judge has yet to rule on the case.

Authored by: Pat Anson, Editor

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Smith

How right you are, Ronnie. They’re not allowed to just blurt that stuff out in the presence of others. It may be advantageous next time to bring a pocket recorder with you to help make individuals like this accountable for their actions.

Ronnie

BL – I use to work for a company who created electronic medical records. I’m very finial at with icd9/10 codes and CPT / Procedure codes.

Ronnie

BL I’m assuming you are a pharmacist …. Please read links that you post before posting them and stating once again they did not violate my HIPPA rights. REGARDLESS if the pharmacist is a healthcare “professional” he DID NOT SPEAK TO ME IN PRIVATE REGSRDING MY HEALTH INFORMATION AND/OR “WHAT AM I GRTTINF TREATED FOR”

Once again he announced to the pharmacy techs, customers behind me at the drop off counter, and people In line waiting to pay and pick up their meds. He announced what am I getting treated for and humiliated me, embarrassed me, and VIOLATED MY HIPPA HEALTH PRIVACY RIGHTS. HE DISCUSS MY HEALTH INFORMATION FROM THE MIDDLE OF THE FLOOR BEHOND HIS COUNTER AND NOT AT THE CONSULTATION DESK….

“the covered entity must have a written business associate contract or other arrangement with the business associate that establishes specifically what the business associate has been engaged to do and requires the business associate to comply with the Rules’ requirements to protect the privacy and security of protected health information. In addition to these contractual obligations, business associates are directly liable for compliance with certain provisions of the HIPAA Rules.”

BL

Pharmacies are A Covered Enitity under HIPPA. Pharmacies fall under A Health Care Provider

The HIPAA Rules apply to covered entities and business associates.-
http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/

BL

Ronnie, just so you know, the codes mean the same thing, it’s kinda like short hand.

Ronnie

Also, No agreement/contract was signed with the pharmacy/pharmacist for him/her to ask a personal health question. CVS or the pharmacist is not a covered entity for him to ask “What am I getting treated for”. That’s a personal health question.

What if you were getting a prescription for an STD and the pharmacist asked you what are you getting treated for? Would you say I’m diagnosed with herpes?

Also, Speaking with the nurse today, She had to do a prior authorization, as starting this month my insurance wants a prior authorization and its a violation of HIPPA for my doctors office to specially state ” Cervical Slipped Disc etc…. ” She’s only allowed to provide an CPT/ICD-9/10 code.

Ronnie

According to my Pain management nurse and doctor. The pharmacist asking what am I getting treated for is a violation of HIPPA. I’m not on Zohydro, and the medication I do take does not require the pharmacist to ask, request, or have the doctor/myself fill out any form.

BL

Ronnie, that is not a violation of HIPPA.

Understanding Health Information Privacy-
http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

Ronnie

Last month when I was refilling my Exalgo ER at CVS it happened so there was a temp/floater pharmacist there and I go through this process normaly where I hand my prescription to the Tech (I’ve been going to this pharmacy for over a year, possibly two now) The Tech ask the pharmacist if they have this medication in stock.

The pharmacist BLUNTLY lied to me while looking at me and said no we don’t carry this/ have this medication. I knew he was liying, because I get it refilled monthly. I informed him to take his little key and open the safe under him and actually look, and what do you know….It was there.

Then, he proceeds to look at the prescription and look at me and state ” What are you getting treated for “. At first I did’t know how to respond, but I informed him that I have a pinched nerves caused by my C7 disc and also have a Syrnix (fluid built up within the spinal cord)

Today I just got off the phone with my PM doctors office and somehow got on the discussion of my pharmacy and why I moved fro Walgreen’s to Cvs… and was informed that him asking me that question is a violation of HIPPA. Is there anyone here who can help me correctly and respectfully do something about this?

BL

KS, I often wonder if one of the reasons that most of the drs have the attitude they do towards chronic severe pain is because in most cases there is no cure. And so far, nothing that can offer the level of help that the pain meds do. Patients expect drs to “fix them” and when the pain comes back or is still there, the patients views what the dr did as a failure and drs don’t know how to respond to this.

KS

Notice once again that this is a new treatment for our pain and not a cure. The reason? If a medication cures a patient, then the drug companies make no money. This is about the money and those of us who suffer daily, hourly, every second need to be cured, not to have the latest drug to help us endure this hell we are going through.

Donna -Pain Care Advocate

I honestly hope that these new formulations work better than what Purdue has in their Oxycontin ER or ENDO has in their Opana ER . These medications were ruined and it has been agreed upon by long term chronic pain patients that these medicines do not work anymore for effectiveness for pain as they once did.
Many chronic painers have turned to methadone now because of this issue.
So here’s hoping that Zogenix comes up with a better med than Purdue if it’s going be the deterrent type because the others don’t break down and release the medicine the properly. Why is everyone always worrying addicts and not caring enough about REAL pain relief for legitimate pain patients? It seems they are catering to the addiction population more so than the legal pain community.

BL

Even though Zohydro ER has ben approved by the FDA and is being sold, There is still a bill in Washington that would ban it. It has a 1% chance of passing as of today, but Rep. Janice “Jan” Schakowsky [D-IL9] is a New Cosponsor.

H.R. 4241: Act to Ban Zohydro-
https://www.govtrack.us/congress/bills/113/hr4241?utm_campaign=govtrack_email_update&utm_source=govtrack/email_update&utm_medium=email

BL

Gina Lewis, often it depends on what is causing the pain, how it is affecting your life and what other forms of pain management you’re using besides medications. Do you have diagnostic test results that show that there may be a cause for your pain ? Are you able to work, go to the grocery store, prepare meals and clean your house ? If you can do these things, the pain isn’t interferring with much. You said you were afraid that your treatment would change. By that I am assuming that you are currenty on pain meds. The drs are learning that the answer is not to continue to increase the pain meds when the pain gets harder to manage. It is the patients responsibility to do all they can so they can keep the pain meds they need at the lowest amount.

I totally agree. Those who are out to abuse will find a way. They always do. What I’m so upset over is the ones like me….chronic pain and no medication prescribed to me has ever managed my back pain.
Now more and more pain Dr’s or pcps are very hesitant to write a prescription to those who really need it. This is a shame. I’m am afraid to even ask for a change in my treatment. I’m always made to feel like a seeker…..always but these abusers…..they have no problem getting these mess. Infuriates me! Meanwhile I lay here awake in pain neatly constantly.

Truth

It has become obvious that the entire Zohydro controversy was/is rooted in a schedule 2 turf battle.

Christina

Why don’t they do a Priority Review on legitimate patients suffering because they do NOT have ACCESS to pain medications their physician are writing them?
I would like to see this matter resolved ASAP. Now half the soldiers coming back from war are in pain. The DEA put majority of pain physician in florida out of business. Tell me Governor Scott why are veterans not getting treatment? This guy needs to go and Pam too.

BL

Bottom line is that if someone wants to abuse this or any other med, they will find a way. The deterrent formulations of Zohydro ER won’t make it any safer to someone who wants to abuse. Nor will it make it any more available to those who suffer fro chronic severe pain.

It all goes back to money. Those that have great insurance and/or money and resources will have access to Zohydro ER. Those that don’t have it won’t have access to it.

I’ve heard in the 4-5 months that pcp’s who have been using hydrocodone combination meds have greatly reduced their prescribing of them in anticipation of the Schedule change. For the few pcps who still do treat chronic pain in their long time patients, I’ve also heard that there have been a steady reduction in the number of tablets prescribed for a 30 day period. I have a great concern that once the hydrocodone combination meds go to Schedule II, that we are going to see more and more people who are having to deal with their chronic severe pain not being managed at all. These are the ones who can’t afford to pay for pain management drs out of pocket. Not everyones insurance covers other pain management options besides meds.