Monday, November 1, 2010

NIDA Misses Mark on Naloxone for Opioid Overdose

Intranasal Naloxone In a prior posting [here] and recently published article [PDF here] we stressed the life-saving potential of at-home naloxone as an overdose antidote for all patients prescribed long-term opioid medications. Along with that we lamented the lack of government or manufacturer interest in supporting such an approach. Now, along comes a U.S. government organization expressing interest; however, they seem headed in the wrong direction.

Briefly, we have written about the demonstrated effectiveness of naloxone for reversing opioid effects and alleviating fatal respiratory depression during overdose. In an emergency, it can be easily and quickly administered via the nose (intranasally) — using a prefilled syringe of naloxone with an atomizer tip — by any family caregiver or bystander who has received about 10-minutes of training (or, in certain cases, by the patient). Another possibility, would be development of an Autoinjector (similar to the well-known EpiPen) for intramuscular injection. Either approach would be inherently safe and should cost perhaps $25, or less. To date, however, neither manufacturers nor government agencies have shown any interest.

It recently came to our attention that one agency, the U.S. National Institute on Drug Abuse (NIDA), a part of the National Institutes of Health, has indeed expressed interest — in a way. They issued a solicitation for a proposal to develop an automated device for administering naloxone to overcome opioid overdose. Here is the entire description of their request…
Development of a Device for Auto-administering Naloxone to Overcome Overdose
Opioid addicts are prone to overdose on injected opiates or on excessive oral doses of opioid medications. These incidents often occur in private settings where no one is present to offer assistance and the addict succumbs to the overdose. Such an event can also occur among patients who are properly medicating for pain, such as in end-stage cancer pain or other unremitting serious pain. To counter inadvertent excess opioid dosing, whether in such patients or in "street" addicts, the proposed research intends to develop and test an automated device that would administer standard doses of naloxone based on the patient's physiologic signal (eg hypoxia, respiratory rate falling below a critical threshold for a critical period of time, etc). The unit would be capable of repeating the injection if necessary, after resetting itself and detecting another set of critical information [emphasis added]. The potential market includes non-addicts who are maintained on high-dose opioids for pain, as well as opioid/opiate addicts, especially those who are maintained on methadone and who may experience overdose if attempting to provide added opioid effects through use of illicit opioids or heroin by injection.
Maybe we’re wrong but this seems like taking a $25 remedy that a child could administer and, instead, creating a sophisticated, automated diagnostic and drug-administration device that could cost hundreds of dollars each and require considerable technical skills for operation. And, it could take many years to develop, test, approve, and market such a sophisticated device, IF it can be designed at all.

The NIDA solicitation comes under the government’s Small Business Innovation Research (SBIR) grants program, designed to stimulate technological advances by small businesses in helping to meet federal research and development needs. It is a 3-phase program, providing $150,000 to demonstrate project feasibility, $1-million over 2 years for a full research and development effort, and expected commercialization of the innovation without government funds. While $1.15 million might be adequate to develop, acquire approval, and market a naloxone Autoinjector, using already proven technology (as in the EpiPen), it would be merely “seed money” at best for the sort of sophisticated automated device described in the proposal request above.

Merely applying for an SBIR grant, with its many pages of forms and requirements, is a daunting task. The deadline for submission is November 8, 2010 and we were notified unofficially that, as of late October, there were no applicants regarding the naloxone device — which is not surprising. It is unknown whether NIDA was merely on a “fishing expedition” to see if someone would take the bait and try to create such a device, or if they wanted to be able to say that they were prepared to fund naloxone for opioid overdose but there were no takers; thus, shifting the blame. Readers may have other opinions — comment below.

RESOURCE: The entire SBIR solicitation document can be viewed [here as a PDF] and the naloxone device described above is on page 93.