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/