FDA pproves Pfizer's Troxyca ER Capsules CII with abuse-deterrent properties for the management of pain
Pfizer has announced that the FDA has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules, for oral use, CII for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Trozyca ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. However, abuse of Trozyca ER by these routes is still possible. It is the only oxycodone with oral abuse-deterrent features described in the labeling.
“Public health authorities and regulators have encouraged the development of treatments that are more difficult to abuse, yet offer pain relief to appropriate patients when used as indicated,” said Rory O’Connor, Chief Medical Officer, Internal Medicine, Pfizer Inc. “The development of this medication with abuse-deterrent properties is another example of our ongoing commitment to advancing science and the treatment of patients with pain conditions.”
Trozyca ER extended-release capsules contain pellets that consist of oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid antagonist. When taken as directed, the naltrexone is intended to remain sequestered and patients receive oxycodone in an extended-release manner. Studies demonstrated that when the pellets are crushed the sequestered naltrexone is released and is available to counteract the effects of oxycodone.
The abuse-deterrent features of Troxyca ER were demonstrated in a battery of in vitro laboratory studies and three clinical abuse-potential studies utilizing crushed Troxyca ER by oral and intranasal routes of administration and the IV route (with simulated Troxyca ER).
Related News
-
News Pharmaceutical industry supports COP28 health stance in joint statement
As COP28 takes place over this week in Dubai, UAE, several bodies in the pharmaceutical and health industries have come together to announce support of key movements in sustainability in the sector, and to recognise sustainability as a health issue.&nb... -
News Biden backs Cold-War measures to shore-up medical supply chains
In a recent strategy to combat rising inflation and the cost of living crisis, President Joe Biden has invoked a Cold War-era act to increase investment in a selection of medicines and supplies. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Novartis agrees for copies to be made of cancer drug to reach poorer countries
Novartis signs agreement with MPP to have generics of it's leukemia drug made so that it can be more easily distributed to the world's poorer countries. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute. -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance