Thursday, January 2, 2020

AG James Facilitates Access To Life-Saving Opioid Overdose Drug

Pharmaceutical Firm Agrees to Renegotiate Terms That May Have

Prevented Supply of Patented Device to Potential Competitors

 New York Attorney General Letitia James today announced an agreement negotiated with Emergent BioSolutions — manufacturers of the successful opioid overdose reversal nasal spray NARCAN — in an effort to increase opportunity for additional companies to utilize the patented, proprietary spray technology that allows for life-saving drugs to be easily administered to patients.

“Given the tragic, devastating effects of the opioid crisis, and the urgent need for additional drugs for the emergency treatment of opioid overdoses, my office will do whatever possible to ensure that there are no unnecessary impediments to the development of additional life-saving opioid overdose reversal drugs,” said Attorney General James. “I’m proud to announce that, starting today, additional companies will be able to gain access to these nasal spray devices. With more companies able to access this easy-to-use technology, our hope is that we can reduce the number of opioid overdose deaths across New York and this nation and save millions of additional lives.”

In February 2016, Adapt Pharma, Inc. launched a naloxone nasal spray, branded as NARCAN, in the United States. While naloxone has been used for decades by first responders and others for the emergency treatment of known or suspected opioid overdoses, NARCAN’s nasal spray device makes it a convenient, non-invasive option that can be used safely, easily, effectively, and without risk by any person without any sort of medical training. In October 2018, Adapt was acquired by Emergent.
The investigation by the Office of the Attorney General revealed that before being acquired by Emergent, Adapt entered into a contract with the manufacturer of the nasal spray device used in NARCAN which may have had the effect of restricting the nasal spray device manufacturer from supplying similar devices to other companies attempting to develop their own nasal nalmefene product — potentially impeding the development of additional life-saving drugs. Clinical literature suggests that nalmefene has the potential to be a successful, life-saving opioid overdose reversal drug.
After Attorney General James laid out her concerns, Emergent and the Office of the Attorney General came to an agreement that would ensure Emergent no longer enforces the terms of the previously negotiated exclusivity contract. Additionally, the agreement will ensure Emergent renegotiates the contract with its nasal spray device manufacturer.

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