#1 Opioid deaths projected to reach 700,000 by 2025 in JAMA study
A study titled “Prevention of Prescription Opioid Misuse and Projected Overdose Deaths in the United States” published on February 1, 2019 in JAMA Network presents a continued stark picture on the opioid crisis.
The study set out to analyze the projected effect of recent policy changes in 2018 to decrease or limit the number of opioid analgesic prescriptions on the future trajectory of opioid overdose deaths in the United States.
There are two key findings. The first is that limiting opioid prescriptions and their misuse has a very modest impact on overall opioid overdose deaths, causing a decrease of 3% to 5.3%.
The second reported finding is that opioid overdose deaths are projected to increase annually by 147% getting up to 81,700 in 2025. (There were over 49,000 opioid-related overdose deaths in 2017.) Between 2016 and 2014, the study projects 700,400 Americans are estimated to die with 80% as a result of illegal opioids, namely fentanyl.
In our Opioid Weekly News 2019 Outlook, we predicted that the statistics would continue to get worse before getting better but we thought the peak in overdose deaths would be reached earlier. This JAMA Network study by projecting opioid overdose deaths to continue rising steadily, presents a grave warning that current policies have to shift to the more difficult ones encompassing treatment, recovery, and social factors including for prevention.
For more information review the published study: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723405
#2 FDA declines to approve Alkermes opioid-based depression drug
Alkermes reports on February 1, 2019, receiving a Complete Response Letter from the FDA, in which approval for their New Drug Application (NDA) for ALKS 5461, a once-daily, oral drug proposed for the adjunctive treatment of major depressive disorder (MDD) is declined at this time.
The company plans to meet with the FDA to review the CRL and determine is there is a viable path forward for ALKS 5461. At this time, the FDA is requesting additional clinical data to provide substantial evidence of effectiveness of the drug for the adjunctive treatment of MDD.
MDD affected around 16.2 million Americans in 2016, and about two in three patients do not respond to currently approved therapies.
The decision is not a surprise given the FDA’s Psychopharmacologic Drugs Advisory Committee voted 21 to 2 against approving the drug in October, 2018, citing that the risk-benefit profile of the entity was insufficient to support its approval.
For more information review the press release from Alkermes: http://phx.corporate-ir.net/phoenix.zhtml?c=92211&p=irol-corporateNewsArticle&ID=2385782
#3 Purdue Pharma OxyContin practices revealed as Massachusetts judge orders public release of documents
A January 31, 2019 ruling from an appellate denying Purdue Pharma’s continued request to keep the court filings under seal ended with the Massachusetts Attorney General releasing their filed document to the public.
Details include that the management consulting firm McKinsey & Company was involved in advising Purdue Pharma about OxyContin, the powerful opioid analgesic that is widely cited as a key driver of the current opioid epidemic. The document notes the involvement of Sackler family members in the day-to-day management decisions related to the drug’s marketing and sales tactics including pushing for more aggressive messaging to increase the number of prescriptions of the drug and at higher doses despite concerns about addiction risks, and approving the incentive compensation structure of the salesforce. Dr. Richard Sackler, a son of the company’s founders had apparently suggested in 2017 that Purdue drop Cigna as the company’s health insurer after Cigna announced it was taking OxyContin off its list of covered drugs, in an effort to endorse safer prescribing practices.
For more information the now publicly available document can be accessed here: https://www.documentcloud.org/documents/5715954-Massachusetts-AGO-Amended-Complaint-2019-01-31.html
#4 Illinois patients can now choose between medical marijuana and opioids
At the end of January, 2019, Illinois state saw its Alternatives to Opioids Act pilot project go into effect, enabling patients to now choose between medical marijuana and opioid analgesics.
Governor Brue Rauner had stated at the time of signing the bill, “This law will give thousands of Illinoisans who struggle with the negative side effects of opioids, including harmful addiction, another choice to manage their pain. This is not about personal opinions about cannabis. It’s about giving people more control over their own health care and pain-relief options.”
The pilot program is tightly overseen by the Illinois Department of Public Health. The program is limited to individuals aged 21 and older. A licensed physician has to certify that a patient has a medical condition for which they have been taking an opioid or would need to be prescribed. Participants must register at a licensed dispensary. Dispensations are limited to 2.5 ounces every 14 days. Patients have to be re-certified every 90 days by a licensed physician.
For more information review the press release from the Illinois Governor’s Office when the bill was signed in August, 2018: Governor signs landmark medical marijuana legislation, Alternatives to Opioids Act of 2018 offers pain-management option – https://www2.illinois.gov/Pages/news-item.aspx?ReleaseID=18112
#5 Alabama latest to make Naloxone available in schools
The Alabama Department of Education and the Alabama Department of Public Health announced on January 30, 2019 a program to make Naloxone available in public high schools as part of the state’s effort to prevent opioid overdose deaths.
Naloxone, which can reverse the overdose effects of opioids and revive a person in an emergency situation, comes in several formulations. The Alabama Dept. of Education will make available the auto-injector version of the drug to high schools.
More information can be found here: http://www.wsfa.com/2019/01/31/state-offer-opioid-reversal-medicine-alabama-high-schools/
IANA Health seeks to be that easy, one-stop online resource for opioid and other substance abuse and addiction information, clinicians, and support groups. https://ianahealth.com.