WISAM On-Demand Recordings
April 26, 2017
Today, Inspirion Delivery Sciences LLC announced that RoxyBond (oxycodone hydrochloride) tablets CII have been approved by the FDA for oral use to manage severe pain requiring an opioid analgesic and for which alternative treatments are insufficient, according to a press release.
“Inspirion is pleased to receive FDA approval for our second abuse-deterrent product, RoxyBond, which is intended to address the long-standing unmet need for immediate-release abuse-deterrent opioids,” Stefan Aigner, MD, CEO of Inspirion, said in the release. “There are nearly 18 million prescriptions for immediate-release oxycodone hydrochloride annually in the U.S. alone.”
RoxyBond uses physical and chemical barriers without aversive agents or opioid antagonists to deter abuse even when subjected to manipulation or extraction, and it is the first and only immediate-release opioid analgesic approved with abuse-deterrent label claims, according to the release. The drug is approved in dosages of 5 mg, 15 mg and 30 mg. According to the release, inactive ingredients in RoxyBond make misuse and abuse more difficult, and in head-to-head trials with another approved oxycodone immediate-release tablet, RoxyBond had higher resistance to cutting, crushing, grinding or breaking, as well as passage through a needle. Furthermore, RoxyBond indicated resistance to extraction in selected household and laboratory solvents under various conditions, whether intact or manipulated. The tablet also makes developing solutions for IV injection difficult. However, it is still possible for abuse to occur via the intranasal, oral and IV route, according to the release.
Researchers performed a clinical abuse potential study.
“As reflected in the prescribing information, the data from the clinical study, along with support from in vitro data, also indicate that RoxyBond has physicochemical properties that are expected to reduce abuse by the intranasal route of administration,” Lynn R. Webster, MD, principal investigator from PRA Health Sciences, said in the release.
The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 19 to 0, with one abstention, to recommend approval of RoxyBond on April 5, 2017, according to the release.
“Oxycodone immediate-release opioid tablets are widely abused and the development of RoxyBond will offer clinicians a new approach for treating patients in pain while also fighting against the potential for abuse,” Jeffrey Gudin, MD, department director of the Pain Management Center Englewood Hospital and Medical Center, said in the release.
Curbing opioid abuse has been a focus over the last several months for the FDA, which earlier this year approved several pain relief agents that are specifically manufactured to make them more difficult to abuse.
Citing the “epidemic of overdose deaths,” the CDC issued guidelines for primary care physicians and other medical professionals for opioid prescriptions last year.
Original Article Link
April 18, Wisconsin Health News
Gov. Scott Walker has signed into law a bill ending state penalties for those who possess cannabidiol without psychoactive effect if they have written certification from a doctor.
The bill also directs the state's Controlled Substances Board to reschedule CBD oil, which is derived from marijuana and sometimes used to treat seizures in children, within 30 days following a change at the federal level. The bill passed the Senate 31-1, and the Assembly 98-0.
The bill builds on a 2014 law that aimed to make the drug available with a prescription in the state. But supporters said that providers weren't able to prescribe the drug, which is still illegal to obtain under federal regulations.
Wisconsin will receive $7.6 million from the federal government to combat opioid addiction, the Department of Health and Human Services announced Thursday night.
HHS is providing $485 million to all 50 states, the District of Columbia and six U.S. territories. The funding, made available under the 21st Century Cures Act, will go toward prevention, treatment and recovery services.
States were awarded funding based on rates of overdose deaths and unmet need for treatment. Florida received the most money at $27.2 million, while five territories received $250,000 each.
Gov. Scott Walker directed the Department of Health Services to seek the funding in an early January executive order. DHS can re-apply for additional funding next year.
Source: WI Health News
by Bob Davis | March 9, 2017
On Monday, March 6th, Republican leadership introduced the American Health Care Act (AHCA). The AHCA is Republican’s plan to repeal and replace the Affordable Care Act (ACA).
The American Society of Addiction Medicine (ASAM) is very concerned that the AHCA’s proposed changes to our health care system will result in reductions in health care coverage, particularly for vulnerable populations including those suffering from the chronic disease of addiction, and we cannot support this bill in its current form.
More than 20 million Americans currently have health care coverage due to the ACA, including millions of Americans with addiction. The ACA expanded Medicaid, required health plans to cover essential health benefits such as addiction treatment, and mandated plans to treat mental health services at parity with medical and surgical services. This coverage is a critical lifeline for people with addiction, many of whom were unable to access treatment before the ACA’s expansion of Medicaid, and has reduced the burden of the opioid epidemic and saved lives.
The AHCA will roll back these important provisions and will certainly reduce access addiction treatment and reverse much or all progress made on the opioid crisis last year.
The AHCA passed out of the House Ways and Means Committee and is being considered by the House Energy and Commerce Committee.