Hypertension drug gets BFAD approval

It’s now official. A new brand of amlodipine camsylate will soon be available in the market, courtesy of Therapharma Inc, a division of United Laboratories (Unilab).

The Bureau of Food and Drugs recently granted a certificate of product registration for the new brand of amlodipine.

The BFAD conducted a stringent evaluation of all documents and samples of the new brand of amlodipine to assess its efficacy and safety and the issuance of its certificate of product registration indicates that it has passed all tests for efficacy and safety.

The new brand of amlodipine will be sold at almost 50 percent lower than the originator brand. This is good news to the almost seven million Filipinos who are suffering from hypertension, most of whom cannot comply with their treatment because of the high price of medicine.

Amlodipine is one of the most scientifically well-documented drugs, which have been shown to be effective and safe in the treatment of hypertension.

A major barrier, however, for a more satisfactory patient compliance is the cost of the medicine. There has long been a clamor among doctors and patients alike on another brand of amlodipine, which is bioequivalent as the innovator brand but is more affordable.

According to a 2004 study published in the journal Clinical Therapeutics, amlodipine camsylate has been shown to be equivalent compared with the formulation of the originator brand of amlodipine.

This was based on pharmacokinetic (bodily absorption, distribution, metabolism, and excretion of drugs) and pharmacodymic (effects of the drug) studies.

The study was conducted among healthy male Korean subjects aged 20 to 40, who all received a single oral dose of either conventional or the newly developed amlodipine camsylate formulation.

Blood samples for pharmacokinetic analysis of amlodipine were obtained during the 144-hour period after dosing. Systolic and diastolic blood pressure and pulse rate were measured prior to each blood sampling.

Furthermore, safety profiles were assessed such as hematology and biochemistry, electrocardiography, urinalysis, and adverse events.

Amlodipine camsylate is a crystalline salt of amlodipine suitable for pharmaceutical formulation. It meets all the required pharmaceutical properties as an effective antihypertensive and anti-anginal agent.

As a calcium antagonist, it blocks the transport of calcium within the microscopic channels in the walls of the coronary arteries. This effect relaxes the artery muscles and dilates the coronary arteries and the peripheral arteries. Such action relieves chest pain and lowers blood pressure.

In a country where hypertension is prevalent and where majority of the population is under the poverty line, the introduction of a safe, effective and affordable medicine is a welcome change.

More and more Filipino patients are clamoring for local pharmaceutical companies such as Unilab to provide them with effective medicines at a price they can afford.