California is taking the first step towards creating a more affordable and accessible supply of Naloxone nasal products through the broader CalRx Initiative, a vital tool in combating the opioid epidemic.
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Under the CalRx Naloxone Access Initiative the state will allocate $30 million to support a partner, or partners, in developing, manufacturing, procuring, and/or distributing a naloxone nasal product under the CalRx label.
“One more fatal overdose is one too many. California is tackling the opioid epidemic from all sides,†said Governor Gavin Newsom. “Naloxone is, quite literally, a lifesaver – so we are making it more accessible and affordable for anyone who needs it.â€
Naloxone is an essential medication used to reverse opioid overdoses and save lives.
Access to this medication is expected to improve with the recent approval by the U.S. Food & Drug Administration of Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray product for over-the-counter use.
However, California recognizes that this development may not sufficiently address the needs of those who are most vulnerable, such as low-income, uninsured, or underinsured individuals and their families.
A more affordable version of this medication is critical to making naloxone more accessible in communities across California.
The Department of Health Care Services created the Naloxone Distribution Project (NDP) in 2018 to combat opioid overdose-related deaths in California through the provision of free naloxone.
As of June 25, 2023, the NDP has distributed more than 2.6 million naloxone kits, resulting in more than 181,665 reported overdose reversals.
CalRx represents a groundbreaking solution for addressing drug affordability.
The state will target prescription drugs where the pharmaceutical market has failed to lower drug costs, even when a generic or biosimilar medication is available.
Compared to traditional procurement of prescription drugs, CalRx seeks deep, mutually beneficial partnerships with companies and non-profit organizations that share the state’s goals.
Earlier this year, Governor Newsom announced CalRx was in the process of bringing to market affordable and accessible insulin generics under the CalRx label that will be available to Californians and people across the country.
The funds provided by the state can support research and development, including clinical studies, manufacturing process development, regulatory submissions, FDA approval, and distribution of naloxone nasal products. ■