FDA Approves Javadin (clonidine hydrochloride) Oral Solution for the Treatment of Hypertension

In continuation of my update on Clonidine

Azurity Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of  Javadin (clonidine hydrochloride) oral solution, the only FDA-approved, immediate-release, ready-to-use oral liquid clonidine formulation for the treatment of hypertension in adult patients to lower blood pressure. Lowering blood pressure has been shown to reduce the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

“Javadin marks a significant advancement for patients and providers managing hypertension,” said Ronald Scarboro, CEO of Azurity Pharmaceuticals. “The ready-to-use oral solution may streamline hypertension care for some patients who have difficulty swallowing capsules or tablets, eliminating the need for tablet cutting, compounding, or applying a transdermal delivery system. Azurity specializes in delivering innovative, ready-to-use solutions that help to simplify dosing and improve accessibility.”

A recent study found that more than a third of adult primary care patients questioned had difficulty swallowing tablets and capsules, and 58.8 percent of them modified their medications—by splitting, crushing, or opening capsules—potentially compromising efficacy and safety.1

“Javadin lowers blood pressure within 30-60 minutes,” added Ajay Singh, Chief Scientific Officer at Azurity Pharmaceuticals. “Unlike many antihypertensive agents that act peripherally, Javadin works centrally by stimulating alpha-adrenoreceptors in the brain, resulting in decreased peripheral and renal vascular resistance, lower heart rate, and reduced blood pressure.”2

Javadin is a berry-flavored, clear, colorless oral solution. Each 5 mL delivers 0.1 mg of clonidine (0.02 mg/mL). Javadin may be used alone or in combination with other antihypertensive agents. Javadin should not be used in patients with known hypersensitivity to clonidine.

Javadin is expected to be available by end of year 2025.

IMPORTANT SAFETY INFORMATION

Javadin (clonidine hydrochloride) oral solution

Indication and Usage

Javadin is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction with Javadin.

Javadin may be employed alone or concomitantly with other antihypertensive agents.

https://en.wikipedia.org/wiki/Clonidine

FDA Approves Javadin (clonidine hydrochloride) Oral Solution for the Treatment of Hypertension

FDA Approves Onyda XR (clonidine hydrochloride) Non-Stimulant Liquid Treatment for ADHD

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the U.S. Food and Drug Administration (FDA) has approved Onyda XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

Onyda XR is the first non-stimulant ADHD medication in Tris’ portfolio, the first-and-only liquid non-stimulant ADHD medication approved in the United States and the only approved non-stimulant ADHD medication with nighttime dosing. Non-stimulant ADHD therapies are an important option for patients who do not respond adequately to stimulant medication or experience negative side effects from them, and they are increasingly used as an effective alternative to stimulant treatments. Onyda XR is expected to be available in pharmacies in the second half of 2024.

“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” said Ann Childress, M.D. “The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control.”

Tris Pharma harnessed the flexibility of its proprietary LiquiXR® technology to develop Onyda XR, a liquid non-stimulant medication with a smooth, extended-release profile that physicians can use to treat ADHD patients either alone or in combination with stimulant therapy. This product adds to Tris’ comprehensive and expanding portfolio of leading ADHD therapies that enhance patient care for individuals with the disorder. The company’s ADHD therapies are available in both oral suspension (liquid) and solid (tablet) forms for administration to children and adults. Tris continues to grow its ADHD offerings with a pipeline of new medications that could have a substantial impact for those with the disorder.

“Securing FDA approval for Onyda XR is not just an important milestone, but a testament to our unwavering commitment to innovating and improving outcomes for this patient population,” said Ketan Mehta, Founder and CEO at Tris Pharma. “Our relentless pursuit to offer a range of ADHD medicines to patients of all ages does not stop here, and we look forward to continuing to expand our portfolio in other ADHD indications.”

The U.S. FDA approval of Onyda XR is based on adequate and well-controlled studies of clonidine hydrochloride extended-release tablets

REF: https://en.wikipedia.org/wiki/Clonidine

FDA Approves Onyda XR (clonidine hydrochloride) Non-Stimulant Liquid Treatment for ADHD