Akums Drugs & Pharmaceuticals, India's leading contract development and manufacturing organisation (CDMO), has launched a DCGI-approved combination of Pregabalin, Methylcobalamin, and Duloxetine (Delayed Release) capsules for the management of diabetic peripheral neuropathic pain associated with Vitamin B12 deficiency.

The launch comes amid a growing burden of neuropathy in India, driven by the rising prevalence of diabetes and nutritional deficiencies.

With more than 100 million people living with diabetes in the country, an estimated 25–50% of patients are expected to develop diabetic neuropathy during the course of their disease. Vitamin B12 deficiency, which is common among urban Indians, further aggravates symptoms such as tingling, numbness, fatigue, and cognitive impairment, highlighting the need for comprehensive treatment approaches.

Peripheral neuropathy is a progressive neurological disorder characterised by burning sensations, tingling, numbness, shooting pain, and loss of nerve function. If left untreated, it can lead to irreversible nerve damage, reduced mobility, sleep disturbances, and a diminished quality of life.

The newly launched formulation combines Pregabalin 75 mg, Methylcobalamin 1500 mcg, and Duloxetine 20 mg/30 mg (Delayed Release) to provide a multi-mechanism treatment approach. Pregabalin helps reduce abnormal nerve activity and relieves neuropathic pain, while Duloxetine works by inhibiting serotonin and norepinephrine reuptake to modulate central pain pathways and help improve associated anxiety and sleep disturbances. 

Methylcobalamin, the active neurological form of Vitamin B12, supports myelin sheath repair, improves nerve conduction, and promotes regeneration of damaged nerve fibres.

A key feature of the formulation is its advanced dual-delivery technology, which enables the immediate release of Pregabalin and Methylcobalamin while delivering Duloxetine in a delayed-release format to the intestine. According to the company, this optimises the absorption of each active ingredient, enhances therapeutic effectiveness, improves patient comfort, and supports long-term treatment adherence.

 Sandeep Jain, Managing Director, Akums Drugs & Pharmaceuticals, said, "India is witnessing a sharp rise in neuropathy cases driven by diabetes, nutritional deficiencies, and lifestyle disorders. Managing this condition requires more than symptomatic relief—it demands a holistic approach that supports nerve repair and long-term neurological health. Our triple-action formulation is a science-led innovation that combines multiple mechanisms into a single, patient-friendly dosage form to improve outcomes and adherence."

Sanjeev Jain, Managing Director, Akums Drugs & Pharmaceuticals, added, "As disease patterns evolve, there is a growing need for therapies that address multiple dimensions of patient care within a single treatment approach. This formulation combines pain management with nerve health support, offering clinicians a comprehensive option for neuropathy management while reinforcing our focus on developing differentiated and clinically relevant therapies for India's healthcare needs."