DCGI nod to Lincoln pharma Diclofenac Rectal Spray for reducing types of pain
The patent has been awarded by the Government of India for "a novel liquid rectal spray dosage form containing diclofenac and its pharmaceutically active salts" valid for 20 years, Lincoln Pharma said in a filing.
New Delhi: Lincoln Pharmaceuticals recently said it has received Indian patent for its diclofenac rectal spray, which is used for alleviating pain from various causes. The patent has been awarded by the Government of India for "a novel liquid rectal spray dosage form containing diclofenac and its pharmaceutically active salts" valid for 20 years, the Ahmedabad-based firm said in a regulatory filing.
The company further said it has necessary approvals from Drug Controller General of India (DCGI) and is planning to launch it in the Indian market by January 2020.
It is also planning to apply for a global patent for this novel solution, the filing added.
Lincoln Pharma said its liquid rectal spray dosage offers faster and better absorption of the drug resulting in quick relief and speedy recovery to patients compared to the existing therapeutic options.
"Clinical trials conducted suggest that diclofenac rectal spray is highly effective in patients suffering from pre and postoperative pain, gynaecological surgery and musculoskeletal disorders such as muscular pain, pain associated with arthritis, acute pain in renal colic and mild body ache," it said.
Commenting on the development, company's Managing Director Mahendra Patel said, "Globally, no liquid formulation of diclofenac for rectal administration is available. Lincoln Pharma will be the first company to introduce this novel solution aimed at better patient compliance, rapid drug release and greater bioavailability."
The company said diclofenac rectal suppository market is Rs 20 crore in India and growing at 16 per cent per annum.
There is a huge export potential for this product and will start product registration in Africa, Latin America and Southeast Asia and gradually expand to other markets, Lincoln Pharma said.