Kentucky’s $42 million ibogaine research proposal could face hurdles

[Photo by Karolina Grabowska from Pexels]

In the battle against the opioid crisis, Kentucky made waves earlier this year by proposing to allocate $42 million to investigate ibogaine May 31, 2023, a potentially risky psychedelic that can curb opioid withdrawal and cravings. The state’s Opioid Abatement Advisory Commission has recently selected Attorney General-elect Russell Coleman’s appointment of Christopher Evans as the new executive director, marking a possible shift in the state’s strategy in evaluating ibogaine.

While not dismissing ibogaine outright, Coleman has signaled plans to focus more comprehensively on opioid use disorder prevention. Coleman also appointed a new executive director, Christopher Evans, a veteran of the Drug Enforcement Administration (DEA).

A more conservative approach in tackling opioid use disorder would be in line with a view of some medical experts, who have que…

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FDA issues draft guidance on opioid-use disorder devices

The FDA today released draft guidance for developers of devices meant to treat opioid-use disorder.

The agency cited the specific challenges of designing clinical studies to evaluate these devices, including inaccurate self-reporting of drug use, missing data, the confounding effects of related drug treatments and the lengthy observation periods needed to demonstrate therapeutic.durability.

For example, the FDA said pivotal device studies to support marketing submissions “should have a well-defined study population, appropriately monitor drug use, control for bias and include an appropriate follow-up period, study participant retention plans and data analysis plans.”

Related: Could minimally invasive neuromod tackle the opioid epidemic?

The FDA wants feedback on the draft guidance to review before finalization. The agency said the guidance doesn’t apply to diagnostics for opioid use or opioid use disorder, combination products, o…

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How fentanyl has transformed the opioid crisis

A potentially fatal dose of fentanyl. [Image courtesy of Wikimedia Commons]

In the 1990s, growing use of painkillers such as Percocet and Oxycodone helped seed the opioid epidemic. Afterward, demand for heroin increased, exacerbating the problem.

More recently, a surge in  synthetic opioid fentanyl use has worsened the crisis. According to the CDC, more than 100,000 Americans now die from drug overdoses yearly. Of those, approximately 75,000 involve opioids, 64,000 of which involve synthetic opioids such as fentanyl.

We spoke with Sarah O’Brien, a business development representative at Ark Behavioral Health, to learn more about the opioid crisis and the role fentanyl is playing in it. 

In the following interview, O’Brien touches on how fentanyl has transformed the opioid epidemic and highlights the importance of accountability in addressing the crisis. 

Fentanyl is up to 50 times…
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Cardinal Health announces $124M settlement of investors’ opioid suit

Cardinal Health directors’ insurers will pay the company $124 million to settle a stockholder derivative action related to the opioid crisis.

The company (NYSE: CAH) on July 22 issued a court-authorized notice to alert investors to a settlement hearing to be held on Oct. 4 in U.S. District Court in Southern Ohio.

If the settlement is entered, it would end nearly three years of hard-fought litigation that sought to prove that present and former board members of Cardinal Health failed in their oversight of the company, according to a plaintiffs motion filed May 25 for preliminary approval of the proposed settlement.

Through their lawyers, the investors claimed that the board members acted with reckless disregard for the best interests of Cardinal by allowing Cardinal to distribute prescription opioids without fully adhering to the laws governing the distribution of controlled substances, including the Controlled Substances Act (the “CSA”). The plaint…

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Teva and Allergan reportedly agree to pay $5B billion to settle opioid allegations

[Prescription pill bottle image courtesy of Pexels]

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and AbbVie unit Allergan Plc (NYSE:ABBV) could pay more than $5 billion in total to settle some 3,500 opioid lawsuits, according to Bloomberg. While the two companies are willing to settle the suits in the consolidated case, the deal has not been finalized.

The consolidated case is titled In Re National Prescription Opioid Litigation, 17-MD-2804, U.S. District Court, Northern District of Ohio (Cleveland).

Teva and Allergan have reportedly been in mediation for more than a year.

In 2016, Teva completed a $40.5 billion acquisition of Allergan’s generic business, including generic opioids.

In 2020, AbbVie acquired Allergan.

Earlier this year, Teva Pharmaceuticals and AbbVie reached a deal with Rhode Island for a total of $28.5 million to settle opioid-related claims.

Teva entered…

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Johnson & Johnson and drug distributors agree to pay $590M in opioid settlement agreement with U.S. tribes

Johnson & Johnson (NYSE:JNJ) and its U.S. subsidiary Janssen Pharmaceutical Companies have reached a $150 million settlement agreement with federally-recognized tribes related to opioid-related claims payable over two years.

The case was filed in the U.S. District Court, Northern District of Ohio, Eastern Division.

The settlement notes that American Indians have one of the highest rates of opioid overdoses per capita in the U.S. Tribal governments have thus been forced to pay considerable sums to “cover the costs of the opioid crisis, including increased costs for health care, social services, child welfare, law enforcement and other government services that Tribes provide to their citizens,” it added.

McKesson (NYSE:MCK), AmerisourceBergen (NYSE:ABC) and Cardinal Health (NYSE:CAH) have reached similar agreements with U.S. tribes.

In all, the companies will pay at least $590 million to settle lawsuits related to opioid medications.

The …

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Johnson & Johnson reaches opioid settlement with Colorado and Nevada

Johnson & Johnson (NYSE:JNJ) has reached a settlement agreement with Colorado and Nevada to put opioid-related allegations there to bed. 

Colorado will receive $385 million from Johnson & Johnson and the drug distributors McKesson (NYSE:MCK), AmerisourceBergen (NYSE: ABC) and Cardinal Health (NYSE:CAH).

Nevada will receive nearly $285.2 million as part of the overall settlement, which is earmarked for battling the ongoing opioid epidemic, according to Nevada Attorney General Aaron D. Ford. Of that sum, Johnson & Johnson will pay $63 million, according to a press release.

“The funds that our state will receive going forward will help us save lives and mitigate the harms done to our residents because of the ongoing opioid epidemic,” Ford said in a statement. “Our team has worked diligently to get Nevada the resources we must have to help Nevadans in need in one of the epidemic’s hardest-hit states, and to obtain justice from many opioid manufac…

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Cardinal Health docks executive bonuses over opioid costs

Cardinal Health CEO Mike Kaufmann (Photo courtesy of Cardinal Health)

Cardinal Health’s board of directors reduced bonus payouts for CEO Mike Kaufmann and his four top-paid executives due to the cost of opioid litigation.

After pressure from investors, Cardinal Health (NYSE:CAH) for the first time has disclosed how its board of directors factored the opioid litigation settlement costs into the pay packages of Kaufmann, Chief Financial Officer Jason Hollar, Pharmaceutical Segment CEO Victor Crawford, Medical Segment CEO Stephen Mason and Chief Legal and Compliance Officer Jessica Mayer.

Kaufmann was eligible for about $2.2 million in annual incentives for fiscal 2021 and received $780,000. The board eliminated any payout to Kaufmann for the earnings component of his annual cash incentive award, but awarded him 40% of his target, according to a new Securities and Exchange Commission disclosure filed Fri…

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FDA seeks more money, authority in budget request

The FDA wants more money from Congress for the coming fiscal year, and more power, too.

Out of its $6.5 billion total budget, the agency is asking $676.55 million for its medical device program. That includes $571 million for the Center for Devices & Radiological Health (CDRH) and $105.4 million for the Office of Regulatory Affairs (ORA).

The request includes $452 million that would come from Congress— up nearly $44 million from FY 2021 — and $224.5 million from user fees, a $4.9 million increase.

Get the full story on our sister site, Medical Design & Outsourcing.

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Purdue Pharma boost settlement offer to $4.28 billion

Purdue Pharma has proposed paying an additional approximately $500 million in cash to settle hundreds of thousands of opioid lawsuits filed against the company.

As part of a proposed bankruptcy settlement, the payments would be spaced out over the next decade. The Sackler family that owns the company has earlier agreed to pay an additional $4.2 billion to settle a range of civil claims. The total settlement amount is roughly $4.28 billion.

Get the full story from our sister site, Pharmaceutical Processing World.

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Purdue Pharma boost settlement offer to $4.28 billion

Purdue Pharma has proposed paying an additional approximately $500 million in cash to settle hundreds of thousands of opioid lawsuits.

As part of a proposed bankruptcy settlement, the payments would be spaced out over the next decade. The Sackler family that owns the company has earlier agreed to pay an additional $4.2 billion to settle a range of civil claims. The total settlement amount is roughly $4.28 billion.

The latest proposal has immediately faced opposition from two dozen state attorneys general.

The proposal, which would also strip the Sackler family of ownership of Purdue Pharma, would need approval from a federal bankruptcy court in White Plains, N.Y.

But the agreement would allow the family to continue managing offshore subsidiaries for at least seven years.

Purdue family admitted in 2007 and 2020 that it illegally marked opioids such as OxyContin in plea deals with the Justice Department.

The latest proposal would turn …

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McKinsey to pay $573M in opioid settlement

The prestigious consulting firm McKinsey has struck a deal with 47 states over its role in the opioid crisis. 

Notably, the company had advised OxyContin manufacturer Purdue Pharma (Stamford, Conn.) on “turbocharging” opioid sales. The pharma company had worked with McKinsey for 15 years. 

The Justice Department concluded that McKinsey helped manage a Purdue Pharma sales program known as “Evolve to Excellence” that pushed medically questionable OxyContin prescriptions.

There is no admission of wrongdoing in the McKinsey settlement, but the firm will publicly share tens of thousands of pages of documents linked to its opioid work. 

“With this agreement, we hope to be part of the solution to the opioid crisis in the U.S.,” said Kevin Sneader, global managing partner of McKinsey, in prepared remarks. 

Sneader also apologized for the firm’s role in the opioid crisis while also maintaining that the firm’s past work with opioid makers was lawful.…

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