#1 FDA approves AcelRx’s Dsuvia, powerful sublingual tablet opioid amid controversy
Despite widespread opposition and warnings, the FDA went ahead on November 2, 2018 and approved Dsuvia, an opioid 10 times more powerful than fentanyl. The FDA Commissioner, Scott Gottlieb, M.D., issued a statement to explain why the FDA went ahead with the controversial approval.
Previously, the FDA Advisory Committee for Anesthetic and Analgesic Drug Products had voted 10-3 in favor of recommending approval for Dsuvia. However, the Chairman of the Committee opposed the decision and wrote a letter to the FDA outlining his concerns including about the drug finding its way on to the streets.
The FDA Commissioner in his statement noted a significant driver for the approval decision was the importance of this drug to the Pentagon. His statement summarized precautions on dispensing that are to be put in place to ensure the drug does not find its way on to the streets or be misused.
#2 Indivior reiterates on target for $1 billion revenues for Sublocade
Individor’s latest earning call on November 1, 2018, indicated that they are expecting continued pricing pressure on its buprenorphine medication assisted treatment Suboxone while anticipating their buprenorphine monthly depot injection of Sublocade to be on track to achieve over $1 Billion in net revenues.
In a statement, the company noted the following in relation to Sublocade –
Since June 30, 2018 and September 30, 2018, formulary access has increased from 56% to 82% of lives covered. The prescription journey duration (time between when the prescription is written and the paperwork processed to approve dispensing) decreased from 27-37 days to 16-22 days.
#3 USDA unveils plans to fight opioid epidemic in rural communities
On October 30, 2018 the USDA and ONCP (White House Office of National Drug Control Policy) introduced a second tool within a month to help rural communities address the opioid epidemic.
The Rural Resource Guide to Help Communities Address Substance Use Disorder and Opioid Misuse is a new, comprehensive “one-stop-shop” resource for rural leaders to find Federal funding and partnership opportunities.
This is the second tool announced this month in USDA’s Community Opioid Misuse Toolbox – a suite of essential tools for supporting grassroots strategies to address the opioid crisis. Earlier in October, the USDA launched the Community Assessment Tool, an interactive database to help community leaders assess how and why the opioid epidemic is impacting their regions.
The USDA’s Community Opioid Misuse Toolbox is free and available to the public here: USDA: Opioid Misuse in Rural America.
#4 Virginia receives CDC grants to continue fight against opioid crisis
Virginia has received $4.9 million from the CDC, the bulk of which over $4 million will be used to strengthen the state’s Department of Health’s emergency response to the opioid epidemic. This includes incident management for early crisis response, recovery, surveillance data collection, surge management, and countermeasures and mitigation.
The state’s Department of Forensic Services will receive $948,000 in equipment and supplies from the CDC for their toxicology section to improve efficiency in drug testing.
#5 Mexico cartels now fueling Chicago opioid epidemic
Chicago which has been a known hub for Mexican heroin and cocaine imports into the United States has now also become an entry point for illicit opioid drugs smuggled from there through established supply lines.
An ABC special will air at 10pm on Monday November 5, 2018 titled “Chapo, Illinois” will review the presence and operations of the Mexican Sinaloa cartel in Chicago.