BDR Pharmaceuticals has, in a global first, introduced prostrate cancer drug enzalutamide in oral solution form, the company said.

The formulation provides “an effective dosage form, with lesser side effects in comparison to existing oral dosage forms of enzalutamide”, a note from BDR said. “The dose reduction, owing to tolerability of the product by patients, is a big advantage of this oral solution, as dose regimen can be adjusted based on the volume of consumption. This flexibility is absent in existing oral dosage forms of enzalutamide,” the company added.

Labelled BDENZA (32 mg/mL), the drug is priced Rs 27,000 for 150 mL. Other generic versions of the oral drug are priced between Rs 6,900 and Rs 27,000 across multiple strengths (40-160 mg) and capsules (strip of 4/ 7/14 tablets or bottle of 28 capsules). The innovator drug from Astellas (40 mg) is pegged at over Rs 3 lakh for a bottle of 112 capsules, according to industry information, though some trade representatives indicated it was not in stock.

An estimated 1.2 million new cases of prostrate cancer are diagnosed globally each year and the disease causes an estimated 375,000 deaths, according to the World Health Organisation. From the eight most common cancer in males in India in the 1990s, it became the third most common around 2015, a note from BDR said.

In India, 37,416 prostate cancer cases were reported in 2016, and the number is projected to touch 47,000 by 2025. Since most of the affected persons are in the older age group, ingesting higher dosages of the medicine becomes difficult, the note said, outlining the need for the alternative dosage form.

According to Dr Aravind Badiger, Director (Technical Formulation), BDR, the oral solution brings a mix of benefits for patients. “It gives a strong 160 mg dose in just one small 5 ml serving, so there’s less hassle associated with lots of pills. Unlike fixed-dose tablets, doctors can adjust the dosage to fit each patient better. This oral solution is gentle on the stomach, avoiding issues like nausea. Plus, it is sugar-free and tastes good, making it easier for patients, especially those with taste changes or dietary limits, to stick with the treatment,” he said. In a nutshell, he said, BDENZA was a simpler, more patient-friendly way to tackle prostate cancer and would help improve patient compliance.

Raheel Shah, BDR Group Director (Business Development), added that the first-of-its-kind oral solution addressed the challenges faced by patients and offered “convenience, reduced side-effects, and a palatable sugar-free taste and affordability.”

The BDR group manufactures active pharmaceutical ingredients (API) and newer formulations. The group comprises BDR Pharmaceuticals International and BDR Life Sciences, in API and formulation manufacturing, respectively. The group focuses on specialised therapeutic segments, including oncology, critical care, gynaecology and neurology.