Controversy Surrounds FDA Approval of New Opioid Drug.
A coalition, formed to fight what it sees as an opioid epidemic, is rallying support against the US Food and Drug Administration’s (FDA) approval of the drug Zohydro.
The FED UP! Coalition is urging supporters to sign a letter to the FDA to fight the agency’s approval of the drug, which it says will increase the opioid epidemic and the number of deaths from overdoses (www.feduprally.org).
In October 2013, the FDA approved Zohydro ER (hydrocodone extended release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. In a press release, the FDA said it is the first approved single-entity (not combined with another analgesic) and extendedrelease hydrocodone product (http://1. usa.gov/1nTm63f). It is a Schedule II controlled substance.
In a January 2014 e-mail, the coalition said Zohydro “could be the next OcyContin.” The group said the FDA approved Zohydro even though the advisory committee it commissioned to review the new drug voted against approval by a 11–2 vote. “This drug is the first form of pure hydrocodone on the US market and does not contain any abuse-deterrent qualities,” the e-mail said.
The coalition said the FDA has already received a letter from state Attorneys General from across the US and letters from members of Congress opposing approval of the drug. It is now soliciting signatures of support from advocacy groups, public and private agencies, and businesses to send to the FDA commissioner. “Our goal is to make a strong statement to the FDA and the media that we will not allow the agency to continue rubber-stamping dangerous new opioid drugs in the midst of a raging epidemic,” the coalition said.
Welcome to the Future: Drug Testing with a Fingerprint
Fingerprint biometrics may be coming to an addiction treatment program near you.
A company from the United Kingdom, Intelligent Fingerprinting, is currently developing a portable drug testing device that will be able to detect multiple drugs of abuse in the sweat from a single fingerprint. The company, based in Norfolk, England, plans to market this new technology later this year.
The device, which the company says is easy to use and provides results in less than 10 minutes, would replace the need for patients to provide traditional body fluids, such as urine, to test for illicit drugs.
It would provide drug testing that’s non-invasive, fast, and cost-effective, to screen for up to five classes of substances: amphetamines, benzodiazepines, cannabis, cocaine, and opioids.
The device works like this: a fingerprint sample is collected on a small receptacle, which is then inserted into the device. The device analyses the sweat in the fingerprint using an immunoassay and provides a pass or fail for each substance class according to predetermined cut-off values. The device will also have the option of capturing a detailed image of the fingerprint that the clinic can use to verify a patient’s identity, with the intended goal of preventing cheating and sample mix-ups. The cost of testing will apparently be comparable to existing methods.
Intelligent Fingerprints, along with addiction medicine experts at the University of Eastern Finland, and the Finnish healthcare technology company Addoz Oy, are beginning clinical trials. The research is funded by a $1.4 million grant from Eurostars, a program for funding research and developing initiatives across Europe. The device is not approved by the US Food and Drug Administration (FDA).