Julia Harder, PharmD, CGP
On Tuesday April 16th, the same day that the patent on the old, non-abuse-deterrent OxyContin formulation was set to expire, the FDA decided to block potential generic versions of the original formulation from being produced. The FDA has issued a statement that it will not approve any abbreviated new drug applications for generics that are based on the original formulation.
The FDA approved the original formulation of OxyContin in 1995. This formulation did not have any abuse-deterrent properties. Drug abusers found that crushing the extended-release tablets enabled rapid release of the drug all at once, producing a fast, powerful high when snorted, injected or even sprinkled on food. OxyContin became known as "hillbilly heroin." That abuse, the FDA said, increased "the risk of serious adverse events, including overdose and death."
In April 2010, the FDA approved Purdue’s reformulated version of OxyContin, designed to resist abuse. The tablets are harder to crush, break or dissolve, and instead of becoming a fine, snortable powder when crushed or broken, a viscous hydrogel is formed, that cannot be easily snorted or injected. Purdue voluntarily withdrew the original OxyContin formulation once the new abuse-deterrent version became available.
The OxyContin reformulation did decrease OxyContin abuse, as demonstrated in a study published in the New England Journal of Medicine in July 2012 (read more about this study here). According to the researchers, before the release of abuse-deterrent OxyContin, 35.6% of patients entering treatment programs throughout the United States were using OxyContin as the primary drug of abuse. Twenty-one months later, after the release of the abuse-deterrent formulation, just 12.8% selected OxyContin as their drug of choice.
The FDA’s decision to block generic OxyContin most certainly represents a win for Purdue Pharma LP, the manufacturer. OxyContin has long been one the nation's top-selling prescription painkillers with sales of more than $2.8 billion last year. The FDA’s decision effectively protects Purdue from lower-price competition by requiring generic companies to develop their own abuse-deterrent designs. Purdue’s abuse-resistant formulation doesn’t go off patent until 2025.
The FDA’s decision also represents a win for those concerned about a resurgence of OxyContin abuse. In a statement, Republican Representative Hal Rogers of Kentucky, a state with a high level of OxyContin abuse, called the FDA decision not to approve generic OxyContin "a huge win for our region and for the thousands of families who have seen painkillers become pain makers. The FDA undoubtedly saved our nation from another deadly tidal wave of oxycodone abuse and overdoses."
Unfortunately for hospice care providers, the FDA’s decision also means that the price of OxyContin is unlikely to decrease any time soon. One of the struggles we face in hospice is the high price of almost every long-acting opioid available on the market today. The following chart compares the cost to the hospice (based on average wholesale price, or AWP) of a 15-day supply of equianalgesic doses of some of the more commonly-prescribed long-acting opioids.
OxyContin 80 mg PO Q12H $422
Opana ER 40 mg PO Q12H $400
Fentanyl patch 100 mcg Q72H $189
Morphine ER tablet 100 mg PO Q12H $106
Avinza 180 mg PO Q24H $500
Kadian 200 mg PO Q24H $420
Methadone 10 mg PO Q12H $12
With the exception of methadone and the lowest strengths of extended-release (12-hour) morphine, long-acting opioids generally cost at least $100 per prescription, and often cost 4-5 times that. Of the long-acting opioids most commonly used in hospice care (morphine ER, fentanyl patch, OxyContin and methadone), OxyContin is, by far, the most expensive – and is likely to remain that way for quite some time.
Two years ago, Purdue Pharma released a new formulation of the widely abused long-acting opioid OxyContin. The new formulation was designed to discourage medication misuse and abuse by being more difficult to cut, break, chew, crush or dissolve to release more medication or use via injection or inhalation. This week, in the New England Journal of Medicine, results were published of a study examining the effect of the new OxyContin formulation on the abuse of OxyContin and other opioids.
The authors collected data for 3 years, starting in July 2009 and ending in March 2012. The data came from anonymous self-administered surveys completed by a total of 2566 opioid-dependent patients entering treatment programs for opioid abuse.
Before the release of abuse-deterrent OxyContin, 35.6% of patients entering treatment programs throughout the United States were using OxyContin as the primary drug of abuse. Twenty-one months later, after the release of the abuse-deterrent formulation, just 12.8% selected OxyContin as their drug of choice. So, it appears the abuse-resistant formulation did its job: it decreased OxyContin abuse.
However, it does not appear that OxyContin abusers stopped abusing opioids altogether. Instead, they moved on to other opioids, including, most commonly, heroin. While Oxycontin abuse declined, abuse of other opioids, especially high-potency opioids like hydromorphone and fentanyl, rose markedly. And perhaps most troubling is the fact that heroin use nearly doubled.
To gather more details, the investigators interviewed 103 patients. Patients unanimously reported a preference for the old version of OxyContin, even though 24% of them had found a way around the abuse-resistant formulation. Most (66%) indicated that the release of the abuse-resistant formulation led them to switch to another opioid, with heroin being the most common choice.
As the authors conclude, “abuse-deterrent formulations may not be the ‘magic bullets’ that many hoped they would be in solving the growing problem of opioid abuse.” Indeed, it appears that the new OxyContin formulation, while achieving the obvious goal of reducing OxyContin abuse, may have caused more problems than it solved by pushing abusers toward heroin, a drug that “may pose a much greater overall risk to public health.” Clearly, a more comprehensive strategy is needed to help these individuals who are suffering from opioid addiction and fight the prescription drug abuse epidemic.
Cicero TJ, Ellis MS, Surratt HL. Effect of Abuse-Deterrent Formulation of OxyContin. N Engl J Med. 2012;367:187-189.
The FDA has approved a new formulation of OxyContin (Purdue Pharma) designed to discourage medication misuse and abuse. The reformulated OxyContin is intended to prevent the product from being cut, broken, chewed, crushed or dissolved to release more medication. This formulation may result in less risk of overdose due to tampering, likely resulting in less abuse by snorting or injection.
However, according to Dr. Bob Rappaport, director of the FDA's Division of Anesthesia and Analgesia Products, the new formulation provides only an "incremental advantage" over the current version of the drug. "Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."
Many addiction experts are skeptical about how tamper-resistant the new formulation will prove to be. According to the FDA, Purdue Pharma will be required to conduct post-marketing analysis on how - or if - the new formula reduces abuse of the drug.
The FDA has granted market approval to Actavis Group for alprazolam 0.25, 0.5, 1, and 2 mg orally disintegrating tablets, indicated for the management of anxiety disorder and the short-term relief of anxiety symptoms. The medication is generically equivalent to Niravam (Schwarz Pharma). The company will begin distributing the product immediately.
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