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Tuesday, June 18, 2024

'Lost Chances to Treat Overdose Survivors Documented in New Medicare Study'

 A new study documents lost opportunities to treat drug overdose survivors covered by the Medicare program -- and illustrates the difficulty of managing chronic pain.

Overdose survivors "should be at the front of the line for the full range of medications and counseling and support," said Brian Hurley, MD, president of the American Society of Addiction Medicine, who was not involved in the research.

Instead, those on Medicare who survived a drug overdose in 2020 were much more likely to later receive opioid painkillers than any medication to treat addiction -- and some went on to die of an overdoseopens in a new tab or window, according to the study findings in JAMA Internal Medicineopens in a new tab or window.

U.S. government researchers found 53% of overdose survivors received opioid painkillers while 4% received treatments such as buprenorphine. Only 6% filled prescriptions for the overdose antidote naloxone. Within a year of their overdose, 17% experienced a second nonfatal overdose and 1% died of an overdose.

The researchers looked at nearly 137,000 Medicare beneficiaries who survived an overdose in 2020, when the emergence of COVID-19 scrambled drug treatment efforts.

The group included about 30% who qualified for Medicare because of a disability rather than their age. About 80% of them had been treated for acute or chronic pain, and nearly half had prescriptions for opioids before the overdose.

In some situations, it might be appropriate to continue to prescribe opioids after an overdose, but "these patients should be closely monitored, provided naloxone," and have plans in place to reduce overdose risk, said lead author Capt. Christopher Jones, PharmD, DrPH of the Substance Abuse and Mental Health Services Administration.

Gaps in treatment for overdose survivors exist throughout the U.S. healthcare system and predate the pandemic, said Michael Barnett, MD, of the Harvard T.H. Chan School of Public Health, who was not involved in the new study, but found similar results among Medicare patients from 2016-2019.

"The health system is very poor at connecting people to life-saving medication after they overdose," Barnett said. "It's a health system problem. And it's also a problem of stigma and public education that many people may not be interested in or may not trust medications for opioid use disorder."

In 2020, Medicare expanded coverage to include methadone to address a longstanding treatment gapopens in a new tab or window. Methadone is the oldest, and experts say, the most effective of the three approved medications used to treat opioid addiction. It eases cravings without an intense high, allowing patients to rebuild their lives.

Medicare still does not cover residential addiction treatment, another gap that should be closed, Hurley said.

https://www.medpagetoday.com/painmanagement/painmanagement/110702

Vaxart cash runway extended to 2026

 — Cash runway extended into 2026 —

— Received one of the largest BARDA-funded Project NextGen Awards to date, up to $453 million —

— Company well-capitalized to execute on multiple key clinical and regulatory milestones in COVID-19 and norovirus programs —

https://www.globenewswire.com/news-release/2024/06/17/2900005/25416/en/Vaxart-Provides-Business-Update.html

Celldex started at Buy by Stifel

 Target $58

https://finviz.com/quote.ashx?t=CLDX&ty=c&ta=1&p=d

GSK Reignites Blenrep Blockbuster Aspirations With Data from Phase III Studies

 After a brief market exit in November 2022, GSK appears to be giving its multiple myeloma treatment Blenrep (belantamab mafodotin) a second chance, with company executives touting its “multi-blockbuster” potential in a virtual oncology-focused investor event on Monday.

Much of GSK’s renewed enthusiasm for the antibody-drug conjugate (ADC) comes from promising data from two Phase III studies—DREAMM-7 and DREAMM-8—which saw strong signals of efficacy in Blenrep-based treatment regimens when used in multiple myeloma patients who had undergone at least one prior line of treatment.

In DREAMM-7, which compared Blenrep against Johnson & Johnson’s Darzalex (daratumumab), GSK reported a “significant increase” in progression-free survival (PFS) in patients treated with the ADC. The Blenrep regimen resulted in a nearly 60% drop in the risk of disease progression or death versus Darzalex. The PFS benefit was statistically significant, with a p-value of less than 0.00001.

In addition, median PFS in the Blenrep arm was 36.6 months, compared to those patients treated with Darzalex who only saw a median PFS of 13.4 months. The difference of approximately 23 months was “statistically significant and clinically meaningful,” according to GSK.

At the time of analysis, Blenrep also showed an “early, strong, and clinically meaningful trend” toward better overall survival (OS) versus Darzalex. DREAMM-7 will continue its follow-up for OS.

The Blenrep regimen also had superior depth of response than the Darzalex treatment, resulting in more than double the percentage of patients achieving at least complete response.

Results from DREAMM-8—which compared a Blenrep-based regimen versus a corresponding treatment schedule that used Takeda’s Velcade (bortezomib)—were similarly promising.

Patients treated with GSK’s ADC saw a “statistically significant and clinically meaningful” decrease in the risk of disease progression or death, which was almost 50% lower than in the Velcade group. Median PFS for Velcade treatment was 12.7 months, while it had not yet been reached at the time of analysis in the Blenrep patients.

The Blenrep regimen also elicited deeper treatment responses than the Velcade schedule. More than twice the percentage of patients in the Blenrep arm achieved complete response or better than those treated with Velcade.

Given these promising data, GSK Chief Commercial Officer Luke Miels estimated during Monday’s investor event that Blenrep could reach peak sales of more than $3 billion, driven mostly by the second-line opportunity in multiple myeloma. Blenrep could eventually dislodge Darzalex as the standard of care in this setting, Miels said.

Blenrep, an ADC that targets the BCMA protein, was originally approved under the FDA’s accelerated pathway in August 2020. At the time, it was authorized as a monotherapy for relapsed or refractory multiple myeloma patients who had progressed after prior treatment with a proteasome inhibitor, anti-CD38 antibody and immunomodulatory agent.

In November 2022, after falling short of its primary efficacy endpoint in its confirmatory Phase III trial DREAMM-3, GSK decided to pull Blenrep from the U.S. market.

https://www.biospace.com/article/gsk-reignites-blenrep-blockbuster-aspirations-with-data-from-phase-iii-studies-/

FDA Partial Hold on Zentalis Azenosertib Clinical Development Program

 FDA has placed a partial clinical hold on ZN-c3-001, DENALI and TETON monotherapy studies of azenosertib

Monotherapy data to be presented in the second half of 2024

Conference call to be held today, June 18, 8:00 am ET

Zentalis will host a live conference call and webcast today at 8:00 a.m. Eastern Time to provide a business update. To access the live conference call by telephone, please register at: https://register.vevent.com/register/BI24249bb9e5714044b9f4057f28565923. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: https://edge.media-server.com/mmc/p/y2wz6vv6. The webcast will also be made available on the Company's website at www.zentalis.com under the Investors & Media section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.

https://www.globenewswire.com/news-release/2024/06/18/2900260/0/en/Zentalis-Pharmaceuticals-Provides-Update-on-Azenosertib-Clinical-Development-Program.html

GeoVax BARDA Project NextGen Award for Phase 2b for COVID-19 Vaccine Candidate

 10,000-participant randomized Phase 2b study will evaluate and compare GeoVax's multi-antigen, vaccine candidate (GEO-CM04S1) to an approved vaccine against COVID-19 under BARDA's Clinical Studies Network

Project NextGen is a $5 billion initiative by the U.S. Department of Health and Human Services to develop innovative vaccines and therapeutics providing broader and more durable protection against current and future COVID-19 viral strains

https://finance.yahoo.com/news/geovax-receives-barda-project-nextgen-110000120.html

Telehealth firm fraud charges may worsen ADHD drug shortage

 Two executives at a telehealth start-up have been arrested and are facing allegations of fraud involving the distribution of medicines for attention-deficit hyperactivity disorder (ADHD).

Ruthia He, the founder and chief executive of San Francisco-based Done Global, and the company’s clinical president David Brody have been charged with participating in a scheme to illegally distribute Adderall and other stimulant drugs used to treat ADHD over the internet, conspiring to commit healthcare fraud, and obstructing justice.

The Department of Justice estimates that they may have generated more than $100 million in revenue from the activity, which provided around 40 million pills to customers who paid for a monthly subscription, even if there was no medical need for them.

The service included a smartphone app that could be used to schedule appointments, coordinate refills, and track symptoms and medication use. It is the first criminal drug distribution prosecution related to telemedicine prescribing through a digital health company, according to the DoJ.

The Centers for Disease Control and Prevention (CDC), meanwhile, has warned that the case against Done Global could exacerbate an ongoing shortage of ADHD medicines in the US.

“Patients who rely on prescription stimulant medications to treat their ADHD and have been using this or other similar subscription-based telehealth platforms could experience a disruption to their treatment and disrupted access to care,” said the agency.

It estimates that as many as 30,000 to 50,000 patients ages 18 years and older across all 50 US states could be affected.

According to a DoJ statement, He and Brody targeted drug seekers with its telehealth network and spent “tens of millions of dollars” on deceptive advertisements on social media. They set up a sophisticated system to maximise revenues; for example, including an auto-refill function, which sent an automated request to prescribers each month so that users could get a fresh supply.

Moreover, Done Global refused to pay prescribers for any medical visits, telemedicine consultation, or time spent caring for patients after an initial consultation, discouraging follow-up care, and based its entire business model on the number of patients receiving ADHD medication prescriptions, it added.

The Drug Enforcement Administration (DEA) has also put out a statement on the arrests, alleging that He and Brody “preyed on Americans and put profits over patients by exploiting telemedicine rules that facilitated access to medications during the unprecedented COVID-19 public health emergency.”

DEA Administrator Anne Milgram noted that there have been shortages of ADHD medicines, including Adderall, since 2022, adding: “Any diversion of Adderall and other prescription stimulant pills to persons who have no medical need only exacerbates this shortage and hurts any American with a legitimate medical need for these drugs.”

If convicted, He and Brody each face a maximum penalty of 20 years in prison on the conspiracy to distribute controlled substances and distribution of controlled substances counts. Brody has reportedly pleaded not guilty to the charges.

https://pharmaphorum.com/news/telehealth-firm-fraud-charges-may-worsen-adhd-drug-shortage