Tamper proof Oxycodone IR. Just got marketing approval today. Goodbye Roxicodone.
I wouldn't say goodbye roxicodone just yet, I imagine there is going to be a large markup on Oxecta and as stated below: "This formulation can still be abused by crushing, chewing, [censored], or injecting the product......There is no evidence that this formulation has a reduced abuse liability compared with immediate-release oxycodone''
I just got a medscape 'pharmacists alert' email linking to an article, you have to have an account to view the article so I copypasta'd it below.
June 20, 2011 — Pfizer Inc and Acura Pharmaceuticals Inc announced today marketing approval from the US Food and Drug Administration (FDA) for a new formulation of oxycodone hydrochloride (HCl), USP tablets (Oxecta) CII. The new formulation is indicated for the management of acute and chronic moderate to severe pain when the use of an opioid analgesic is appropriate.
The product is an immediate-release oxycodone medication that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse, the companies said in a statement. This technology, known as Aversion Technology, uses commonly available pharmaceutical ingredients that, for example, cause the active ingredient to gel to prevent injection or to irritate nasal passages to discourage inhalation. Pfizer is licensing the technology in this product from Acura.
"Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments," the companies note in their statement. "However, abuse and misuse of opioids is a serious public health issue that is the focus of a number of recent United States government initiatives."
In April, FDA released its long-awaited opioid plan, changing regulations for long-acting and extended-release opioids. The central component of the new opioid Risk Evaluation and Mitigation Strategy is an education program for prescribers. The agency will require drug makers to provide and pay for the plan, although the training is still not mandatory for prescribers.
Important Safety Information
This new product is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment in any patient who has or is suspected of having paralytic ileus, in patients with acute or severe bronchial asthma or hypercarbia, and in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product, the company release notes.
Respiratory depression is the primary risk. This is more common in elderly or debilitated patients, in those with conditions such as chronic obstructive pulmonary disease, severe asthma, or upper airway obstruction, or after large initial doses of opioids given to nontolerant patients.
The product contains oxycodone HCl, an opioid agonist and a Schedule II controlled substance. "Oxecta can be abused in a manner similar to other opioids and narcotics," the release states. "This should be considered when prescribing or dispensing oxycodone HCl in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse."
This formulation can still be abused by crushing, chewing, [censored], or injecting the product. "These practices pose a significant risk to the abuser that could result in overdose and death," the companies point out. There is no evidence that this formulation has a reduced abuse liability compared with immediate-release oxycodone, they note.
Tablets should be taken with enough water to ensure complete swallowing immediately after placing in the mouth and must be swallowed whole. Because the formulation is not amenable to crushing and dissolution, it should not be used in nasogastric, gastric, or other feeding tubes because it may cause obstruction of the tubes.
Patients who have not been receiving opioid analgesics should start taking this drug in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain, the companies' release adds. The dose should be titrated based on the individual patient's response to their first dose. Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable pain relief and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis. When a patient no longer needs treatment after long-term use, it is important to gradually taper this product over time to prevent withdrawal symptoms, they note.
Patients taking this product in combination with other medicines, such as sedatives, anesthetics, or narcotics, may have serious problems, such as respiratory depression, low blood pressure, profound sedation, or coma, the statement adds.
I was just about to link the same article! I got the RN email about it. I wonder if this is the IR oxy that has niacin mixed with it. I have googled it, and I can't find any pertinant information on it other that it has an Abuse deterrant in it.
There are a few possible things the abuse deterrent could be. Google "Aversion technology" and go to the acurapharm site/result. Niacin is one possibility as is a pill that isn't strictly water soluble.
Niacin...I could see how that would be a good abuse deterrent; but how will it effect people who take the med as prescribed? I can see some ppl having some very unpleasant side effects. Niacin (specifically niaspan) was recently implicated in possibly increasing the risk of a stroke in ppl using statins.
Obviously not going to ban Roxicodone right away, just part of the process. The most important part that I see many are missing, as I was informed via the press release, is that the medication MUST BE SWALLOWED WHOLE. Cannot be halved, etc. It's all part of prohibition-er REMS.
Niacin when taken orally in low doses doesn't have that bad of an effect on a person. When the pill is crushed and abused, would produce unpleasant effects. If you were to take too many, you would probably get profuse sweating, flushing and an upset stomach. That is my guess, maybe CGM could provide better insight?
edited/k - too much detail
Pfizer and Acura Pharmaceuriclas are the ones who are putting out Oxecta. However, Acura and King Pharmaceuticals developed Oxecta under the name Acurox.
The deterrents to abuse in Oxecta (Acurox) are three fold and are proprietary. Acrua's "Aversion Technologies" came up with the plans, and has had it in testing for the past several years.
To reduce injection and nasal use it has a compound in it that causes the medicine to gel. This is somewhat like the technology in OxyContin and Remoxy. It also has Niacin in it, which causes facial flushing and itching at high doses.
There has been some literature put out that Acurox deterrents are really not enough, and for the price, it is not worth it. Most of this has been put out by BioLogic Equity Research LLC, out of Delray Beach, FL. So, to avoid any bad press that Acurox may have had, it looks like they decided to change the name to Oxecta.
Since it has just been FDA approved, there is no package insert available for it yet (at least not on the internet). But, if you want to read up on the medicine itself, look under the older name.
Thanks cgm, I knew we could count on you!
I found the prescribing info for Oxecta, here are some snippets from it. I will post the PI link at the bottom of the post.
Tablets: 5 mg and 7.5 mg (oxycodone HCl)
The pharmacokinetics of oxycodone after OXECTA administration are characterized by peak plasmaconcentrations occurring on average within 1.2 to 1.4 hours of the first dose under fasted conditions.Thereafter, oxycodone concentrations fall with an average terminal half-life ranging between3-4 hours. OXECTA is bioequivalent with Oxycodone immediate-release tablets in the fasted state,with no differences identified in the time to peak exposure (Tmax) and terminal elimination half-life(T1⁄2) of oxycodone between administration of OXECTA and Oxycodone immediate-release tablets.Dose proportionality was established for OXECTA at doses of 5 mg, 10 mg, and 15 mg (oxycodoneHCl) based on proportional increases in oxycodone Cmax and AUC exposure levels.Food EffectWhen administered with a high fat meal, mean AUC values are increased by 21% and peakconcentrations are decreased by 14%. Food causes a delay in Tmax from 1.25 to 3.00 hours. Thesechanges in oxycodone pharmacokinetics are not considered clinically relevant; therefore, OXECTAcan be taken without regard to food.
For future ID of the pills:
OXECTA (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:5 mg tablets debossed with the strength “5” on one side and the King Logo on the other side.
7.5 mg tablets debossed with the strength “7.5” on one side and the King Logo on the other side.
Here is what the pills contain, I do not see niacin listed:
OXECTA contains oxycodone HCl, USP as the active analgesic ingredient.The tablets are round, convex, white and debossed with the strength (5 or 7.5) on one side and KingLogo on the other side. OXECTA also contain colloidal silicon dioxide NF; crospovidone NF;magnesium stearate NF; microcrystalline cellulose NF; polyethylene oxide NF; and sodium laurylsulfate NF.Chemically, oxycodone HCl is 4,5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one HCl,a white, odorless crystalline powder. Oxycodone HCl is soluble in water (1 g in 6 to 7 mL).
Here is the link to download the prescribing information:
We read the press release re: who was gonna push it. The real point of the post was this is the beginning of the end for oxycodone IR as we know it. I'd bet dollars to donuts the "gel" is quite similar to Oxycontin OP that everyone who was on the OC's seems to have such great results with. This could be the ONLY oxy IR of the near future. There's nothing in the constitution to prevent the DEA from withdrawing all other single entity oxy IR products.
I bet most insurance companies will not pay for this "new" IR version. It states that this has not been proven to be any less abuse resistant than the original. But I bet it comes at a MUCH higher cost than the generic.
If you google "Adversion Technology", you will get to the Acura R&D site. Under "Products", you will note that there is Acurox and Acurox with Niacin.
So the new Oxecta is the same as the basic Acurox. It has a technology similar to the OxyContin OP and Remoxy.
As to oxycodone IR going away, I don't think so. It is one of the best medicines for acute post-op, trauma pain, for use as an outpatient medicine. However, all of the pharmaceutical companies have been tasked to make all of their controlled medicines less accesable to abuse, or risk them being pulled from the market.
So, if you say that it may be the end of IR medicnes as we know them now, then probably yes. But, oxycodone will be around in some IR form.