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Morning Briefing

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Friday, Aug 13 2021

Full Issue

'Date Rape' Drug GHB Gets Official Use As Hypersomnia Treatment

Gamma-hydroxybutyrate is tightly regulated, but the Food and Drug Administration has now approved it as a treatment for rare cases of idiopathic hypersomnia, giving it another lease of life. Meanwhile, the Drug Enforcement Agency shut down a Texas drug company over regulation violations.

In the 1960s, the drug was given to women during childbirth to dampen their consciousness. In the 1990s, an illicit version made headlines as a 鈥渄ate rape鈥 drug, linked to dozens of deaths and sexual assaults. And for the last two decades, a pharmaceutical-grade slurry of gamma-hydroxybutyrate, or GHB, has been tightly regulated as a treatment for narcolepsy, a disorder known for its sudden sleep attacks. Now, the Food and Drug Administration has approved the drug for a new use: treating 鈥渋diopathic hypersomnia,鈥 a mysterious condition in which people sleep nine or more hours a day, yet never feel rested. (Hughes, 8/12)

In news about the opioid crisis 鈥

The Drug Enforcement Administration on Wednesday shut down operations at a Sugar Land pharmaceutical company and seized millions of controlled pills after the company reportedly violated regulations, the agency said.聽Investigators with the DEA Houston Division served immediate suspension orders to Woodfield Distribution, LLC, and Woodfield Pharmaceuticals, LLC, for failing to control the diversion of controlled substances and creating "imminent danger to public health and safety," according to authorities. ... The company illegally imported more than 200 million opioid pills and failed to account for more than 5 million pills, the DEA said. (Bauman, 8/12)

Purdue Pharma鈥檚 quest to settle thousands of lawsuits over the toll of OxyContin and its other prescription opioid painkillers entered its final phase Thursday with the grudging support of many of those who have claims against the company. But the lingering opposition from some state attorneys general took center stage in the first day of a confirmation hearing in U.S. Bankruptcy Court about the company鈥檚 reorganization plan. (Mulvihill, 8/12)

Here鈥檚 one more lesson from the COVID-19 pandemic: It appears safe to relax restrictions on methadone, the oldest and most stigmatized treatment drug for opioid addiction. Last spring, with coronavirus shutting down the nation, the government told methadone clinics they could allow stable patients to take their medicine at home unsupervised. Early research shows it didn鈥檛 lead to surges of methadone overdoses or illegal sales. And the phone counseling that went along with take-home doses worked better for some people, helping them stay in recovery and get on with their lives. (Johnson, 8/12)

In other pharmaceutical and biotech industry updates 鈥

For the first time, researchers yesterday reported that a monoclonal antibody can prevent malaria in humans. A team based at the National Institute Allergy and Infectious Diseases (NIAID) Vaccine Research Centers published their phase 1 clinical trial results yesterday in the New England Journal of Medicine. The monoclonal antibody, called CIS43LS, was developed from a neutralizing antibody isolated from the blood of a volunteer who had received an investigational malaria vaccine. Researchers examined whether the monoclonal antibody could safely prompt high-level protection against experimental exposure to infected mosquitoes. (8/12)

A bipartisan group of senators sent a letter to Amazon Friday raising questions about its collection of biometric data. The lawmakers are particularly interested in the expansion of the company鈥檚 palm print scanners program, Amazon One. The scanners are used at Amazon stores to let customers pay without having to take out cards or cash if they enroll in the program. (Rodrigo, 8/13)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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