D.C. Week: Implant for Opioid Addiction Wins FDA Approval

WASHINGTON -- A new device intended to increase compliance with maintenance therapies for those battling opioid addiction won FDA approval this week.

Implant for Opioid Addiction Wins FDA Approval

The FDA approved an implantable version of buprenorphine (Probuphine) to treat opioid dependence in patients who are already stable on a low dose of the drug, the agency said.

Physicians will have to be trained and certified in how to insert and remove the implant, which is comprised of four rods, each an inch long, that are placed under the skin on the inside of the upper arm for 6 months.

Each implant will contain about 80 mg of buprenorphine, for a total of 320 mg being implanted at once, according to Behshad Sheldon, president and CEO of drugmaker Braeburn Pharmaceuticals. The drug will be released at a constant, low-level dose, the FDA said.

Back in the Senate, Rubio Tackles Drugs

Florida's successful efforts to shut down its pill mills led to the current wave of heroin addiction in that state, a county official told a Senate committee Thursday.

"I have ... evidence [that] the increase in the flow of heroin and increases in deaths related to heroin [are] in correlation to our cutting off the 'pill mills,'" said Teresa Jacobs, the mayor of Orange County, Fla., at a Senate hearing on the what some are terming a heroin epidemic. "The cartels have flooded us with very, very cheap drugs."

"In 2010, Florida was known as the pill mill capital of the country," Jacobs continued. "Florida practitioners were prescribing oxycodone at levels exceeding all other states combined. We responded by outlawing unauthorized pain clinics. Today the battlefront has moved; today we fight heroin, today we fight fentanyl. One can only surmise that the drug cartels perceived us as a ripe marketplace."

FDA Slammed for Rush to Approval of Cancer Drugs

A new study has called into question the standards used by the U.S. Food and Drug Administration to approve new cancer drugs and whether those drugs are helping patients live longer.

The paper, which was published in Mayo Clinic Proceedings, assessed 25 drugs approved under the agency's accelerated approval program between 2009 and 2014. The authors found that 14 of those drugs -- 56% -- did not have supporting evidence backing the correlation between the surrogate measure used for approval and actual overall survival. Among 30 drugs approved under traditional approval, 11, or 37% were similarly lacking evidence of survival benefit.

Surrogates include objective response rate, time to progression, and disease free survival. None of these surrogates are required to align with overall survival, thus a drug that improves disease free survival may demonstrate no true survival benefit.

Frieden Presses Case for Zika Funding

"When an earthquake hits we understand the need to respond. Now imagine if you had the power to stop an earthquake," said CDC Director Thomas Frieden, MD, MPH, at a National Press Club luncheon on Thursday.

"We together, using the tools of public health, have the power to stop the health equivalent of many earthquakes," he said, referring to the Zika virus outbreak and the danger it poses in the U.S. with mosquito season beginning.

President Obama requested $1.9 billion in funding to fight the Zika outbreak in February.

Sanofi T2D Combo Injection Wins FDA Panel Support

An FDA advisory committee threw its support behind a new combination diabetes drug, despite major concerns about the product's unique design and labeling, on Wednesday.

The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 12 to 2, with one abstention, to recommend approval of Sanofi's insulin glargine and lixisenatide injection also known as IGlarLixi -- a fixed ratio product proposed for treating adults with type 2 diabetes.

To date, all approved antidiabetic combinations are either made of two individual fixed dose products or two individual titratable products. This new dual therapy combines a fixed dose product -- the GLP-1 agonist -- and a titratable product -- insulin.

House Republicans Offer Obamacare Alternative

Two congressional Republicans presented a new bill for a free marketplace alternative to the Affordable Care Act (ACA), which they modestly christened the "World's Greatest Healthcare Plan Act of 2016," on Monday.

Rep. Pete Sessions (R-Texas), who co-authored the new bill along with Sen. Bill Cassidy, MD (R-La.), argued their proposed plan is more sustainable than the ACA, and better suited to patients' individual needs.

"We still have too many darn people that are uninsured," Sessions said. But premiums and deductibles are just too high, in part because plans cover services patients don't need, he stated.

Next Week

Congress is out on recess.

On Wednesday, the Consortium of Multiple Sclerosis Centers Annual Meeting begins in National Harbor and runs through Saturday.

On Thursday and Friday, the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee will explore reports of nontuberculous mycobacteria (NTM) infections that may be linked to heater-cooler devices used during cardiac surgical procedures.

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D.C. Week: Implant for Opioid Addiction Wins FDA Approval