On July 2, 2024, the US FDA approved Kisunla (kih-SUHN-lah, donanemab-azbt) for the treatment of Alzheimer’s disease in people with early symptomatic Alzheimer’s disease. A characteristic marker of Alzheimer’s is amyloid plaques. These plaques are caused by an accumulation of naturally occurring amyloid protein and deposits in the brain, affecting cognition, memory, and executive function. Kisunla is a monthly injection that targets amyloid plaques. Kisunla helps the body remove excess amyloid, resulting in an average 61%-84% reduction of plaques, depending on the length of treatment. Alzheimer’s treatments have the greatest potential effects the earlier in the disease timeline they are implemented. Kisunla is approved for people with mild cognitive impairment (MCI) and those with mild Alzheimer’s dementia with a confirmed amyloid pathology. Jacksonville Center for Clinical Research participated in the TRAILBLAZER clinical trials. Eli Lilly and Company says Kisunla should be available to authorized specialty distributors for ordering this month.

Source: https://investor.lilly.com/news-releases/news-release-details/lillys-kisunlatm-donanemab-azbt-approved-fda-treatment-early

On May 31, 2024, The US FDA approved Moderna’s mRESVIA(R) respiratory syncytial virus (RSV) vaccine for adults over 60 years of age. RSV is a highly contagious virus that infects the lower lungs and can cause pneumonia. It causes thousands of deaths per year among older patients in the United States. One of the major structures needed for RSV to infect a host cell is the fusion, or F glycoprotein. This structure enables the virus to merge with human cells and deliver its contents. mRESVIA(R) is an mRNA vaccine, the first mRNA vaccine to be approved other than for COVID-19. This vaccine instructs our cells to recognize and destroy the F glycoprotein present on RSV, providing significant protection of the lower airway from infection. Jacksonville Center for Clinical Research and Fleming Island Center for Clinical Research participated in the Phase II ConquerRSV Trials. Moderna expects mRESVIA(R) to be available for the 2024-2025 RSV season.

Sources: https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-U.S.-FDA-Approval-for-RSV-Vaccine-mRESVIAR/default.aspx

On March 14, 2024, the US FDA granted accelerated approval for Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) with diet and exercise for the treatment of Nonalcoholic Steatohepatitis (NASH), also known as Metabolic Dysfunction-Associated Steatohepatitis (MASH). NASH, a form of fatty liver, affects around 5% of adults in the United States and can lead to debilitating liver failure over the long term. Rezdiffra selectively activates thyroid hormone receptor-β. When combined with diet and exercise, this significantly decreases liver fibrosis and can lead to NASH resolution. Rezdiffra has been the target medication of multiple clinical trials at ENCORE Research Group sites. Jacksonville Center for Clinical Research, Nature Coast Clinical Research – Inverness, and St. Johns Center for Clinical Research have all participated in trials involving Rezdiffra. Madrigal expects Rezdiffra to be available to limited pharmacies in April 2024.

Source:

https://ir.madrigalpharma.com/news-releases/news-release-details/madrigal-pharmaceuticals-announces-fda-approval-rezdiffratm

Two ENCORE Research Group sites, Nature Coast Clinical Research and ENCORE Borland Groover Clinical Research, played a vital role in the clinical trials for “Vibrant,” a new vibrating drug-free capsule designed to treat constipation. In August 2022, the product received clearance from the FDA to be marketed and used for the treatment of constipation. The capsule recently became available for prescriptions as of February 2023.

Vibrant’s unique drug-free treatment works by using gentle vibrations to stimulate the colon mechanically, thus improving its natural motility. The pre-programmed timing of the vibrations is based on the colon’s biological clock, which makes the treatment effective and gentle.

Vibrant’s Phase 3 clinical trial results showed an increased number of complete bowel movements and an improvement in patients’ quality of life. The trial also reported a low incidence of diarrhea at just 1.2%.

It’s important to note that Vibrant is a prescription-only treatment, and it should be recommended by a physician based on the patient’s medical needs and suitability. The treatment’s effectiveness and low incidence of side effects make it a promising option for those struggling with constipation.

Sources:

https://www.vibrantgastro.com/

https://www.medscape.com/

We are excited to announce another FDA approved drug that was tested at ENCORE Research Group’s Nature Coast Clinical Research office In Crystal River Florida. Upneeq™, is a drug to help adults with blepharoptosis, or ptosis, which is a condition where there is an abnormal drooping of the upper eyelid causing a loss in vision. Upneeq™ is currently the only FDA approved medical treatment for drooping eyelids (ptosis).

For more information about this, view the full press release here:

https://www.osmotica.com/