Articles related to Clinical Pharmacology

Unveiling a new path in osteoarthritis pain management, the FDA’s Breakthrough Therapy designation for resiniferatoxin marks a promising development. The FDA has granted Breakthrough Therapy designation to resiniferatoxin for treating osteoarthritis knee pain. Extracted from a cactus-like plant, resiniferatoxin, a potent TRPV1 agonist, boasts similarities to capsaicin. Notably, its potency sets it apart. Resiniferatoxin is administered through intra-articular injection, promoting pain relief by temporarily disabling TRPV1-expressing nociceptors. This unique mechanism targets one of the most profound symptoms of osteoarthritis: pain. Its potential benefits are eagerly awaited by millions of patients struggling with this relentless disease. Stepping up to the challenge, Grünenthal, the company behind resiniferatoxin, is launching a global Phase 3 program. They aim to enroll more than 1,800 patients with knee osteoarthritis who haven’t found sufficient relief from existing non-surgical treatments. With a focus on improved pain and physical function scores according to the WOMAC osteoarthritis index, the program’s efficacy endpoints are set for up to 52 weeks. Turning the tide in osteoarthritis treatment, the Breakthrough Therapy Designation offers an expedited path for this non-opioid therapy option. As Grünenthal’s Chief Scientific Officer, Jan Adams, optimistically noted, it is hoped that this designation will speed up resiniferatoxin’s availability to patients.

Uncover the sweeping developments in telemedicine prescribing of controlled substances and how they impact your pharmacy. The DEA and SAMHSA recently extended the ability for clinicians to prescribe controlled medications through telemedicine until November 11, 2023. Initially, this extension was set to expire on May 11, 2023, as the COVID-19 Public Health Emergency (PHE) ended. Previously, in-person visits were necessary for these prescriptions. The new rule offers continuity of care for patients, according to Christopher M. Jones, the Director of the CDC’s National Center for Injury Prevention and Control. The rule might be extended or shortened depending on when the DEA and SAMHSA’s final regulation is effective. In March, these agencies had proposed reverting to the initial in-person prescribing requirement for controlled medications. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 instated this requirement to mitigate the risk of dependence on these medications. However, the agencies received almost 40,000 comments when they proposed to reinstate in-person visits, many emphasizing the benefits of telemedicine. Telemedicine enables more individuals to access treatments they otherwise couldn’t. This feedback has influenced the decision to maintain the telemedicine option for at least another six months. This extension gives the agencies time to consider […]

Dive into the implications of the FDA’s approval of nirmatrelvir+ritonavir, the first oral antiviral pill for COVID-19. The FDA’s recent approval of nirmatrelvir+ritonavir (Paxlovid, Pfizer) marks a significant advancement in COVID-19 treatment. This oral antiviral, the first of its kind, targets mild to moderate cases in high-risk adults. It’s the fourth drug, but the first pill, to gain FDA approval for treating adult COVID-19 patients. Nirmatrelvir+ritonavir will remain available under emergency use authorization, ensuring continued access for adults and for eligible 12-18 year olds. However, it’s not approved for pre- or post-exposure COVID-19 prevention. Patrizia Cavazzoni, MD, the director for the FDA’s Center for Drug Evaluation and Research, applauded the drug’s approval. She stressed the agency’s commitment to advancing new prevention and treatment options. The efficacy of nirmatrelvir+ritonavir comes primarily from the EPIC-HR clinical trial. This trial studied nonhospitalized symptomatic adults diagnosed with SARS-CoV-2 infection. In the study, nirmatrelvir+ritonavir reduced COVID-19–related hospitalizations or deaths by 86% compared to placebo when used within five days of symptom onset. Almost equal numbers of patients received nirmatrelvir+ritonavir and a placebo. Only 0.9% of the combo pill group were hospitalized or died within 28 days of follow-up, compared to 6.5% in the placebo group. […]

Dive into how the FDA-approved Farxiga is changing the heart failure treatment landscape. Colleagues, let’s dive into a remarkable milestone. Farxiga, known as dapagliflozin, now has FDA approval. This is groundbreaking for heart failure treatment. It applies to all patients, regardless of their left ventricular ejection fraction (LVEF) status. The approval didn’t happen overnight. Let’s talk about the DELIVER trial, a vital part of the process. It involved over 6,000 patients, all over 40. Each had heart failure, LVEF above 40%, and may or may not have had type 2 diabetes. They took either dapagliflozin or a placebo daily, plus their usual therapy. The trial had a clear goal: time to the first composite event. This included CV death, heart failure hospitalization, or an urgent heart failure visit. The goal applied to everyone, including patients with LVEF less than 60%. Fast forward about 2.3 years, the results were significant. Dapagliflozin cut the composite outcome by 18% versus the placebo. Both worsening heart failure and CV death rates dropped in the dapagliflozin group. The best part? These findings were consistent, even in patients with lower LVEF or diabetes. Expanding the picture, let’s consider two trials together: DELIVER and DAPA-HF. Over 22 […]

Delve into the changes in the updated Beers criteria and their implications for medication use in older patients. The American Geriatrics Society (AGS) has recently revised the Beers criteria. Significantly, these guidelines advise physicians to be cautious when prescribing medications like warfarin and sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients over 65. Importantly, warfarin is now a drug to avoid in initial therapy for venous thromboembolism or nonvalvular atrial fibrillation unless alternatives are contraindicated or face significant usage barriers. The Beers criteria are organized into five distinct categories. These include potentially inappropriate medications, ones that might be inappropriate for patients with certain conditions, medications requiring careful usage, potential drug-drug interactions, and medications needing renal function-based dosage adjustments. An expert panel sifted through evidence from June 1, 2017, to May 31, 2022, to create these updates. These guidelines apply to patients aged 65 years and older in most care settings in the US, excluding hospice and end-of-life care situations. Among the notable changes since 2019 is the inclusion of warfarin. For older patients using warfarin long-term, continuation might be reasonable if they show well-controlled international normalized ratios and no adverse effects. Additional drugs introduced since 2019 include ticagrelor and SGLT2 inhibitors (use […]

The United States is currently experiencing a shortage of Adderall, a medication used to treat attention deficit disorder (ADD)/attention deficit hyperactivity disorder (ADHD) and narcolepsy. The FDA, in frequent communication with manufacturers, has not provided a clear timeline for when the shortage will be resolved. The shortage is attributed to various factors. The demand for Adderall has increased significantly, with a 10% rise in prescriptions filled in 2021 compared to the previous year. The US Drug Enforcement Agency’s efforts to combat prescription drug misuse have also played a role in limiting production. Furthermore, the pandemic led to the emergence of telemedicine startups, making it easier for individuals to obtain Adderall prescriptions, sometimes inaccurately. While waiting for the supply to be restored, healthcare professionals can consider alternative therapies such as dexmethylphenidate, methylphenidate, and dextroamphetamine.