The U.S. Food and Drug Administration has granted marketing authorization to the Cue COVID-19 Molecular Test, which is a nucleic acid amplification test designed to detect genetic material from the SARS-CoV-2 virus present in nasal swabs from adults with signs and symptoms of upper respiratory infection. This is the first-ever at-home test authorized by the FDA using a traditional premarket review pathway for any respiratory illness, and it is also the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities.

The Cue COVID-19 Molecular Test is a molecular nucleic acid amplification test, consisting of a single-use Cue COVID-19 test cartridge, a single-use Cue sample wand, and the Cue cartridge reader. It uses the Cue Health app to display results when the test is complete, and the reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the app in about 20 minutes. In a study reviewed by the FDA, the test correctly identified 98.7% of negative and 92.9% of positive samples in individuals with signs and symptoms of upper respiratory infection.

There is a risk of false positive and false negative results, and individuals who test positive should avoid spreading the virus and should seek follow-up care with their physician or healthcare provider as additional testing may be necessary. Negative results should be confirmed by a lab-based molecular test if necessary for patient management.

The FDA has established criteria called special controls that define the requirements related to labeling and performance testing, and they have created a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway. The FDA has granted the marketing authorization to Cue Health Inc.

For more information, please read the press release: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-covid-19-home-test-using-traditional-premarket-review-process

More news on the topic: https://www.labpulse.com/business-insights/policy-and-regulation/regulatory-approval/article/15540028/cue-health-granted-first-traditional-fda-authorization-for-athome-test-to-detect-respiratory-illness

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https://stmdailynews.com/category/lifestyle/health-and-wellness/fda-cdc-news/

The United States Food and Drug Administration (FDA) has announced additional steps to modernize clinical trials in an effort to increase efficiency and improve patient outcomes. The agency has released draft recommendations and is seeking feedback on how they should be applied to increasingly diverse trial types and data sources.

The new guidelines aim to address challenges in clinical trial design and execution, including the use of real-world evidence (RWE) and increasing diversity in clinical trial populations. The FDA recognizes the importance of incorporating RWE in clinical trials to provide a more comprehensive understanding of a drug’s safety and efficacy in real-world settings. The agency is also committed to increasing diversity in clinical trials to ensure that all patient populations receive equal access to potentially life-saving treatments.

The draft recommendations suggest new approaches to trial design, such as the use of adaptive designs and master protocols, to increase efficiency and reduce costs. Adaptive designs allow for changes to be made during the trial based on emerging data, while master protocols enable multiple drugs to be tested simultaneously in a single trial. The FDA also recommends the use of innovative trial designs, such as basket and umbrella trials, which allow for the testing of multiple drugs in a single trial on patients with similar genetic profiles or disease types.

The FDA is also exploring the use of decentralized clinical trials, which rely on technology to enable patients to participate in trials from their homes. This approach has the potential to increase participation in clinical trials and reduce the burden on patients who may have difficulty traveling to study sites. The FDA acknowledges that the use of technology in clinical trials has the potential to improve efficiency and reduce costs while maintaining the integrity of the data.

Finally, the FDA is committed to increasing diversity in clinical trials by encouraging the inclusion of underrepresented populations, such as women, racial and ethnic minorities, and the elderly. The agency is exploring ways to incentivize the inclusion of these populations in clinical trials and is partnering with patient advocacy groups to increase awareness and understanding of the importance of clinical trial diversity.

In conclusion, the FDA’s draft recommendations for modernizing clinical trials represent a significant step forward in improving patient outcomes and increasing efficiency in drug development. By incorporating RWE, innovative trial designs, and technology, while also increasing diversity in clinical trial populations, the agency is working to ensure that all patients have equal access to potentially life-saving treatments. The FDA is requesting feedback on these draft recommendations, and it is hoped that the final guidelines will reflect the input of a diverse range of stakeholders.

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https://www.fda.gov/news-events/press-announcements/fda-announces-additional-steps-modernize-clinical-trials?utm_medium=email&utm_source=govdelivery

https://stmdailynews.com/category/lifestyle/health-and-wellness/health/

Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine. 

“Buprenorphine is an important treatment option for opioid use disorder. Today’s approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will continue to take the critical steps necessary to pursue efforts that advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA’s Overdose Prevention Framework.”

Buprenorphine is a safe and effective medication for the treatment of OUD. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), patients receiving medication for their OUD cut their risk of death from all causes in half.

The FDA continues to implement a comprehensive approach to increase options to treat OUD. Earlier this month, the agency issued a joint letter with SAMHSA to clarify the importance of counseling and other services as part of a comprehensive treatment plan for OUD, and to also reiterate that supplying buprenorphine should not be made contingent upon participation in such services. The agency also held a virtual public workshop that highlighted the need for additional strengths and dosing regimens for extended-release formulations. 

Brixadi is approved in both weekly and monthly subcutaneous injectable formulations at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available. The weekly doses are 8 milligrams (mg), 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, 128 mg. The approved weekly formulation in various lower strengths offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence. Brixadi will be available through a Risk Evaluation and Mitigation Strategy (REMS) program and administered only by health care providers in a health care setting.

The most common adverse reactions (occurring in ≥5% of patients) with Brixadi include injection-site pain, headache, constipation, nausea, injection-site erythema, itchy skin at the injection site (injection-site pruritus), insomnia and urinary tract infections. 

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The safety and efficacy of Brixadi were evaluated in a behavioral pharmacology study assessing the ability of two weekly doses of Brixadi to block the subjective effects of opioids, and one randomized, double-blind, active-controlled clinical trial in 428 adults with a diagnosis of moderate-to-severe OUD. After an initial test dose of transmucosal buprenorphine, patients were randomized to treatment with Brixadi plus a sublingual placebo, or active sublingual buprenorphine plus placebo injections. After titration over the first week, patients were treated with weekly injections over 12 weeks and then transitioned to monthly injections for an additional 12 weeks. A response to treatment was measured by urine drug screening and self-reporting of illicit opioid use during the treatment period. Patients were considered responders if they had negative opioid assessments at the end of each of the two treatment phases. The proportion of patients meeting the responder definition was 16.9% in the Brixadi group and 14.0% in the sublingual buprenorphine group. 

The FDA granted approval of Brixadi to Braeburn Inc.

The agency remains focused on responding to all facets of substance use, misuse, substance use disorders, overdose and death in the U.S. through its FDA Overdose Prevention Framework. The framework’s priorities include: supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing; encouraging harm reduction through innovation and education; advancing development of evidence-based treatments for substance use disorders; and protecting the public from unapproved, diverted or counterfeit drugs presenting overdose risks.

Related Information

• FDA Overdose Prevention Framework
• Information About Medicated Assisted Treatment (MAT)
• Removal of DATA Waiver (X-Waiver) Requirement (SAMHSA)
• Timeline of Selected FDA Activities and Significant Events Addressing Opioid Misuse and Abuse