Oral-lyn, the first buccal insulin – taken through the inner lining of the mouth – has been approved to be part of the US Food & Drug Administration’s treatment investigational drug programme. This programme is meant to give early access to investigational drugs to patients who have life-threatening or serious medical conditions and have been failed by existing therapies. Such patients are not already part of ongoing clinical trials to prove the drugs’ safety and efficacy. Oral-lyn’s maker – Canadanian biotech firm Generex – is currently conducting phase three trials on Oral-lyn.
A Generex press release says under a structured protocol, Generex Oral-lyn will be provided to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for the treatment of diabetes, and who are not eligible to participate in the company’s ongoing global Phase III pivotal clinical trial.
Only selected doctors who are part of the treatment protocol will be allowed to prescribe it.
Now, this is the same buccal insulin that was forced off the market by the Drugs Controller General of India, and rightly so. Oral-lyn, branded Oral Recosulin in India, was being made commercially available for both type 1 and type diabetes without any trials having been conducted here, according to the newspaper Mint. Generex’s Indian partner Shreya Life Sciences had managed to get approval from the current DCGI Dr Surinder Singh’s predecessor Dr Venkateswarulu (who recently passed away). In March it announced that Shreya had secured over 100 orders in the first month of marketing “reflecting the demand for a pain-free” insulin.
When Recosulin was approved here, the only other country that it was available in was Ecuador. Lately, Algeria has been added to that list.
This is an example of how companies can be only as good as the regulators who govern them. Or what explains the completely different paths that the same product has taken in two markets. Sure, no new product goes through full-blown trials for every market, but first-time launches are usually approved here on the basis of phase three trials done locally. Approvals from either the US FDA or EMEA also are deemed important. This time, though, caution seems to truly have been thrown to the winds.
Interestingly, Generex still says it makes Oral-lyn available in India, in its press release.