Oral Recosulin insulin spray hits Indian market

Prick-free alternative to painful insulin shots.

Oral Recosulin, an oral insulin spray for diabetics, which does away with the need for daily insulin shots, have entered India. The recombinant human insulin Oral Recosulin can be administered through mouth. Oral Recosulin can be used to treat both type 1 (starting from childhood) and the chronic type 2 diabetes. The oral insulin is marketed in India by Shreya Life Sciences.

How does one use the oral insulin spray? Recosulin can be sprayed onto the mucosal lining under the tip of the tongue using an inhaler device which is vey much like the one commonly used to take asthma medications. The delivery device is called Recojet. Shreya Life Sciences, the new insulin is already available in major cities including Mumbai, Bangalore, Delhi, Kolkata, Chennai and Cochin since the beginning of 2009. 

Though it is more convenient than conventional insulin injections, the insulin spray Recosulin comes with a price. Recosulin costs about Rs 2,200 for a two vials pack. Each vial has 80 insulin puffs. Each Recosulin puff is equal to one unit of injectible insulin. Conventional insulin vials contain 300 units for injection and costs somewhere between Rs 150 and 180 with minor variations from brand to brand.

Said Shreya Group chairman Sujit Kumar Singh: “Diabetes is one of the major diseases in India and diabetes therapy has immense potential. Shreya has entered the area of diabetes care as a serious long-term player and introduced oral antidiabetics, diabetes-specific nutrients and recombinant human insulin. We are committed to bringing world-class diabetes therapy to India and are making major investments in manufacturing, R&D and marketing to make diabetes therapy affordable to a larger number of patients.” Shreya Life claims that Recosulin can be taken just five to 10 minutes before food. The company claims Oral Recosulin has a fast and high peak of 30 to 50 minutes and a short duration of action of 120 to 150 minutes. 

Oral Recosulin is the Indian brand name of the original Generex Oral-lyn from the US based Generex Biotechnology Corporation, a company specialising in drug delivery technologies. The US firm claims Generex Oral-lyn is the first insulin product to be delivered through the buccal (mouth) route. Earlier, leading companies including Pfizer and Eli Lilly had made unsuccessful attempts to develop alternative, prick-free delivery method for insulin product. Exubera, the inhalable insulin from Pfizer, which was recalled from the US market in 2007 is an example. 

Unlike inhalable insulin which could lead to pulmonary (lung) deposition as it is directly pumped into the lungs, Generex Oral-lyn is a safe, simple, fast, effective, and pain-free alternative, Generex said. 

India’s Biocon, a leading player in biotechnology, is another company reportedly working on an oral insulin pill. The insulin tablet, which can taken as any other ordinary pill, is learnt to have completed phase 2 human trials.

Though Generex Oral-lyn has secured regulatory approval for sale in India and Ecuador, the product is yet to be reviewed for marketing authorisation in the US and EU countries. Generex currently wants to promote the product in emerging markets such as South America, the Middle East, Asia and North Africa. 

At present, WHO has estimated that there are 40 million people who suffer from Diabetes in India and by 2025 the number will increase to 72 million.

Generex claims to have developed RapidMist, an advanced buccal drug delivery technology, a proprietary formulation and a proprietary device design that is able to deliver drugs through the buccal mucosa safely, thereby eliminating the pain from and need for multiple injections.  RapidMist™ has been shown to have a rapid onset of action with no lung deposition, precise dosage control, easy use and handling, and improved patient compliance.