CVS announced it will add 12 states to its program to sell the opioid overdose antidote naloxone without a prescription, bringing the total to 14. The company already sells naloxone without a prescription in Massachusetts and Rhode Island.
“Over 44,000 people die from accidental drug overdoses every year in the United States and most of those deaths are from opioids, including controlled substance pain medication and illegal drugs such as heroin,” Tom Davis, Vice President of Pharmacy Professional Practices at CVS, said in a statement. “Naloxone is a safe and effective antidote to opioid overdoses and by providing access to this medication in our pharmacies without a prescription in more states, we can help save lives.”
The states included in Wednesday’s announcement are Arkansas, California, Minnesota, Mississippi, Montana, New Jersey, North Dakota, Pennsylvania, South Carolina, Tennessee, Utah and Wisconsin. According to The Huffington Post, pharmacy boards in these states can make decisions about offering naloxone without a prescription.
Full story of CVS to sell Naloxone without prescription at drugfree.org
Ending prescription drug abuse is not easy. It’s a complex problem, and solving it is going to take a complex solution made up of many components. One such component capturing the spotlight recently is the development and marketing of so-called “abuse-deterrent formulations” (ADFs) of extended-release/long-acting (ER/LA) opioid pain relievers. Policymakers are touting these medications as being so important that they are willing to consider legislation requiring that ADFs be used for all ER/LA opioid prescriptions. What many of those policymakers apparently haven’t considered, however, is how much this is going to cost, and who is going to bear that cost.
First, let me just say this about the term “abuse-deterrent”: it’s a misnomer. Currently approved ADFs are designed either to make it hard for people to crush, cut or otherwise alter the pills obtained from the pharmacy (e.g., OxyContin®, Hysingla®) or with a sequestered opioid antagonist that is released if the product is altered, rendering the opioid totally ineffective if it is ingested (e.g., Targiniq®, Embeda®). Other ADF mechanisms are envisioned in the draft guidance issued by the U.S. Food and Drug Administration (FDA) in 2013, but the common theme for all of them is an attempt to discourage people from altering the medication to snort, inject, smoke or otherwise ingest it by an unintended route. Doing this with an ER/LA opioid is dangerous because the medication in it is intended to be released over 12 to 24 hours, but when altered and taken by another route, the entire dose of the drug hits the bloodstream immediately, increasing the risk of overdose exponentially. ADFs deter this kind of abuse; but what they don’t deter is the most common form of abuse: swallowing more of the intact medication than is intended. In a sense, the “ADF” acronym really ought to stand for “alteration-deterrent formulation.”
Full story of opioid abuse deterrent at drugfree.org
After the Food and Drug Administration (FDA) decided last year not to approve implantable buprenorphine to treat opioid abuse, researchers have begun a new study to address the agency’s concerns about the product, called Probuphine.
The study will compare Probuphine to buprenorphine/naloxone which is taken under the tongue. Approximately 190 patients are being enrolled in the study at about 20 sites around the country. They will be randomly assigned to receive either an implant of Probuphine in the upper arm, along with placebo tablets under the tongue; or a placebo arm implant, along with buprenorphine/naloxone tablets. Probuphine implants are designed to be effective for at least six months.
The study participants are people treated for opioid dependence who have been stable while taking buprenorphine/naloxone for several months, without using any illicit opioids, says Frank Vocci, Ph.D., co-principal investigator.
Full story of opioid treatment with buprenorphine at drugfree.org