FDA Approves Norliqva (amlodipine) Oral Solution for Hypertension and Coronary Artery Disease

In continuation of my update on amlodipine besylate

The U.S. Food and Drug Administration has approved Norliqva (amlodipine) oral solution for the treatment of:

• Hypertension in adults and children 6 years and older, to lower blood pressure.
• Coronary artery disease [Chronic Stable Angina, Vasospastic Angina (Prinzmetal’s or Variant Angina) and Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.]

• Amlodipine is a widely used long-acting calcium channel blocker first approved by the FDA thirty years ago. It is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure, and is thought to reduce the total peripheral resistance and inhibit coronary spasm to relieve angina.

  Amlodipine is FDA approved under the brand names Norvasc (amlodipine oral tablets) and Katerzia (amlodipine oral suspension), and the oral tablets are also available as generics.

  Norliqva is supplied as a peppermint flavored oral solution containing 1 mg/mL amlodipine as the besylate salt. It is administered once daily.

  Most common adverse reactions to amlodipine include edema, dizziness, flushing and palpitation which occurred in a dose related manner. Other adverse reactions not clearly dose-related but reported with an incidence >1.0% are fatigue and nausea.

https://www.webmd.com/drugs/2/drug-5891/amlodipine-oral/details

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

FDA Approves Conjupri (levamlodipine maleate) for the Treatment of Hypertension

 The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that Conjupri® (levoamlodipine maleate) tablets has received marketing approval from the U.S. Food and Drug Administration (FDA) for the treatment of hypertension. Based on our knowledge, this is the first New Drug Application (NDA) ever submitted to the FDA by Chinese pharmaceutical companies, and now granted full approval following a standard review by the FDA.

Levoamlodipine is the purified (S)-amlodipine, the pharmacologically active enantiomer in amlodipine (a racemic mixture of (R)- and (S)-amlodipine), for the treatment of hypertension. Amlodipine is a third-generation calcium channel blocker first developed and marketed by Pfizer as NORVASC® (amlodipine besylate) tablets in 2.5 mg, 5.0 mg, and 10.0 mg in 1992. The approved Conjupri® (levoamlodipine maleate) tablets come in 1.25 mg, 2.5 mg and 5.0 mg.

Levoamlodipine maleate tablets have been marketed by the Group as Xuanning ( 玄寧) in China since 2003. The clinical development of levoamlodipine maleate tablets in the U.S. was based on the safety and efficacy data demonstrated in China and data showing that levoamlodipine has less adverse events than amlodipine.

This NDA approval allows the Group to market Conjupri® in the U.S. and also paves the way for marketing in other parts of the world. As the first levoamlodipine approved by the FDA, Conjupri® is qualified to be the reference standard for drugs with the same active ingredient.

The NDA approval of levoamlodipine maleate tablets in the U.S. is a manifestation of the Group’s commitment to innovation and to bringing the best medicines to patients worldwide.

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

FDA Approves Consensi (amlodipine and celecoxib) for Treatment of Hypertension and Osteoarthritis Pain

  

In continuation of my update on amlodipine and celecoxib

Kitov Pharma Ltd. an innovative bio pharmaceutical      co.,  announced  that the U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine and celecoxib) oral tablets for marketing.                               amlodipine                                                     celecoxib      

Consensi is a patent-protected combination of celecoxib, a non-steroidal anti-inflammatory drug (NSAID), and amlodipine besylate, an antihypertensive calcium channel blocker. Consensi was approved for once daily use in three dosage forms, corresponding to the current approved dosages of amlodipine (2.5, 5, and 10 mg) for hypertension and a 200 mg dose of celecoxib for the treatment of osteoarthritis pain.

“We are very pleased with Consensi’s approval and would like to thank the members of Kitov’s team, consultants and investigators, as well as the FDA’s Division of Cardiovascular and Renal Products, for all of their support and assistance,” said Dr. J. Paul Waymack, Chairman of Kitov's Board and Chief Medical Officer. “Consensi provides a safe and effective combination treatment option for the millions of Americans who suffer from osteoarthritis pain and hypertension.

“Now that Consensi has been approved for marketing, our clinical and regulatory teams will focus on leveraging their drug development expertise to advance NT219, an exciting investigational new drug candidate currently in development for various oncology indications.”

Isaac Israel, Kitov’s CEO, added: “This approval demonstrates the Kitov team’s ability and experience in expertly guiding Consensi through clinical trials and regulatory review, from Investigational New Drug (IND) submission to FDA approval in less than four years.

“Over 50 million Americans suffer from osteoarthritis. About 1 of 3 U.S. adults or about 75 million people have high blood pressure*, known as the “silent killer” due to the absence of noticeable symptoms. As a result, patients’ adherence to the hypertension treatment regimen is low. We believe that Consensi, as a single pill combination treatment for osteoarthritis and hypertension, presents a unique value proposition of potentially increasing treatment adherence.

“We recently expanded our commercialization network for Consensi by securing a second licensing agreement in Asia with a major Chinese pharmaceutical company. The FDA approval of Consensi puts us in a stronger position towards securing commercial partnerships for the U.S. and other key territories.”

The FDA-approved Consensi New Drug Application included the positive results from the Company’s Phase III clinical trial. These data demonstrated that the study met its primary endpoint of showing that the drug lowers daytime systolic blood pressure by at least 50% of the reduction in blood pressure achieved in patients treated with amlodipine besylate only, with statistical significance of p=0.001. Kitov also submitted the positive results from its randomized double-blind, placebo-controlled renal function Phase III/IV clinical trial of Consensi. Data from this study validated the primary efficacy endpoint achieved in the completed Phase III clinical trial. This study also demonstrated that treatment with Consensi led to a statistically significant reduction of serum creatinine, a marker of renal function, from its baseline value (p=0.0005), demonstrating improved renal function in patients treated with the combination. In contrast, neither amlodipine besylate nor placebo lowered creatinine to a statistically significant level.

Osteoarthritis: pivotal Phase III trial successfully meets primary efficacy endpoint - Medical News Today

Celecoxib/amlodipine besylate (KIT-302)

  

itov Pharmaceuticals, an innovative biopharmaceutical company focused on late-stage drug development, announced today that the Phase III, double-blind, placebo-controlled clinical trial for its leading drug candidate, KIT-302, successfully met the primary efficacy endpoint of the trial protocol as approved by the U.S. Food & Drug Administration (FDA). Data from the trial further revealed that KIT-302 was more efficacious at reducing hypertension than the widely used hypertension drug amlodipine besylate. Kitov plans to file its New Drug Application (NDA) for marketing approval of KIT-302 with the FDA in the second half of 2016.

A combination drug, KIT-302, simultaneously treats pain caused by osteoarthritis and treats hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. KIT-302 is comprised of two FDA approved drugs, celecoxib (Celebrex®) for the treatment of pain caused by osteoarthritis and amlodipine besylate, a drug designed to treat hypertension.

The trial protocol, approved by the FDA through the Special Protocol Assessment process, was designed to quantify the decrease of hypertension in patients receiving KIT-302. The trial was performed in the U.K. in four groups of twenty-six (26) to forty-nine (49) patients, with a total of 152 patients. Each patient was treated over a total period of two weeks. Group One was treated with KIT-302, comprised of celecoxib and amlodipine besylate. Group Two was treated with amlodipine besylate only, one of the components of KIT-302. Group Three was treated with celecoxib only, the other component of KIT-302. Group Four was treated with a double placebo. The trial began in June 2014 and was completed in November 2015.

Osteoarthritis: pivotal Phase III trial successfully meets primary efficacy endpoint - Medical News Today