High-profile drugs under the legal spotlight in 2023

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In the wake of the COVID-19 pandemic, the U.S. has witnessed a surge in litigation. One factor driving the uptick in the pharmaceutical sector is the rise of copycat litigation. As mass tort activity amplifies, plaintiff lawyers are treating previously filed lawsuits as templates for new claims. Examples of the trend include steadily increasing nitrosamines litigation and allegations of laminal duct obstruction against the chemotherapeutic agent Taxotere (docetaxel), as Greenberg Traurig has noted. Additionally, plaintiff-affiliated labs are intensifying their efforts to test various products for potentially harmful chemicals.

Amidst this backdrop, the heartburn medication Zantac (ranitidine) has found itself at the center of a litigation storm. Data from X-Ante, a litigation analysis firm, reveals the drug is the most frequent drug target of mass tort TV advertising in 2023 based on estimated ad s…

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FDA issues draft guidance on opioid-use disorder devices

The FDA today released draft guidance for developers of devices meant to treat opioid-use disorder.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The FDA wants feedback on the draft guidance to review before finalization.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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Johnson & Johnson announces opioid settlement with West Virginia

Johnson & Johnson (NYSE:JNJ) has agreed to pay $99 million to put opioid-related claims in the State of West Virginia to bed. 

The state has removed J&J from an ongoing trial in Kanawha County. 

West Virginia will use the funds to support community efforts targeting the opioid crisis.  

The settlement did not include an admission of liability or wrongdoing. 

The settlement related to former sales of the drugs Duragesic (fentanyl transdermal system), Nucynta (tapentadol) and Nucynta ER, which 

West Virginia had accused Janssen, Teva and Allergan of violating state laws related to shipping opioids. 

In January, J&J announced similar deals with Colorado and Nevada.   

In 2015, Johnson & Johnson divested U.S. license rights for Nucynta-based products. 

The company permanently discontinued sales of Duragesic transdermal systems in 2020. 

JNJ shares were up 0.16% to $180.22 in morning trading.

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Oklahoma State Supreme Court sides with J&J in opioid lawsuit

The Oklahoma State Supreme Court has overturned a 2019 opioid judgment against Johnson & Johnson (NYSE:JNJ) amounting to $465 million.

Five of the six Oklahoma Supreme Court’s justices dismissed the state’s case claiming that Johnson & Johnson breached its “public nuisance” laws in its marketing of prescription opioid drugs. “Oklahoma public nuisance law does not extend to the manufacturing, marketing and selling of prescription opioids,” the five justices wrote in their majority opinion.

Johnson & Johnson had argued that the judgment was flawed, arguing that the state did not show evidence that Johnson & Johnson caused a public nuisance in Oklahoma and that its claims violated core principles of due process.

Johnson & Johnson said in a press release that its prior sales of prescription opioids were “appropriate and responsible” but that the company has stopped selling such drugs as part of a larger effort to focus on new drug develop…

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Why Tryp Therapeutics is exploring the use of psilocybin to treat chronic pain

Many researchers are exploring the potential of the psychedelic compound psilocybin to treat conditions such as depression and post-traumatic stress disorder.

But psilocybin offers broader therapeutic promise as it appears to spur neuroplasticity, according to Greg McKee, CEO of Tryp Therapeutics (San Diego).

The company is exploring the use of psilocybin-based drugs for treating eating disorders and chronic pain.

“There’s a lot of similarities mechanistically in terms of how psilocybin works to treat depression that we think could apply to treating pain,” McKee said.

Tryp is working with researchers who believe psilocybin can support neuroplasticity in a manner that reduces chronic pain. Tryp’s research partners believe psilocybin can help correct abnormal neural firing in patients with chronic pain and related conditions.

Greg McKee

If psilocybin promotes neuroplasticity in huma…

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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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Pear Therapeutics touts cost-effectiveness of opioid use disorder treatment

Pear Therapeutics today touted analysis of its reSET-O therapeutic for opioid use disorder (OUD) that demonstrated cost-effectiveness.

Boston-based Pear Therapeutics’ reSET-O is the first and only FDA-authorized prescription digital therapeutic for treating OUD, according to a news release.

Get the full story at our sister site, Drug Delivery Business News.

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