MannKind ‘aggressively’ moving forward with inhalable epinephrine

By Dan Stanton contact

- Last updated on GMT

MannKind working on an alternative to autoinjectors for epinephrine delivery. Image: iStock/smartstock
MannKind working on an alternative to autoinjectors for epinephrine delivery. Image: iStock/smartstock

Related tags: Food and drug administration

MannKind Corporation met with the US FDA last month to discuss a single-use disposable epinephrine inhaler it says could be an affordable alternative to the Epipen.

In January 2016​, MannKind gave a positive spin to the news that Sanofi was pulling-out of its commercialisation partnership for the inhalable insulin product Afrezza by telling investors at the JP Morgan Healthcare Conference about the opportunities to regain and self-market its lead project, as well as investigate its proprietary Technosphere delivery platform with a number of candidates.

A year on, and CEO Matthew Pfeffer told the same audience that within its pipeline, an epinephrine programme is “the only one that’s still moving forward aggressively,”​ and the firm had a pre-IND (Investigational New Drug) meeting with the US Food and Drug Administration (FDA) in early December to discuss clinical pathways for the anaphylaxis candidate.

“That was a major step for us,”​ Pfeffer told delegates in San Francisco, and while he would not further details of the programme for now, he stressed the need to have “some alternatives in that space.”

Epi-inhaler?

Mylan’s EpiPen is the only epinephrine product available in the US, after Sanofi abandoned another marketing deal last year, this time with Kaleo for the Auvi Q injector​. And a series of price hikes has led the US government to question the lack of competition​ and put pressure on the FDA to improve the generic drug review process.

“Most of the technology [in developing] and existing products use auto-injector mechanisms,”​ Pfeffer said. “All too often, people are reluctant to either stab themselves in the leg with this rather scary looking needle or the cost of at $250 or $300 a pop unless they are really sure they need it, they don’t want to do that.”

MannKind’s candidate will be a single-use disposable, he revealed. “It’s a simple couple of pieces of plastic, relatively affordable as you might imagine and we think it makes a nice alternative [to the EpiPen].”

The handheld inhaler will comprise of the mouthpiece of the Afrezza inhaler with a cartridge built into it.

Like Afrezza, ephinephrine will be delivered using MannKind’s Technosphere platform which uses the excipient fumaryl diketopiperazine (FDKP) – highly soluble at pH 6.0, the prevailing physiological pH in the lungs – in order to avoid both hepatic first pass metabolism and degradation in peripheral circulation in the delivery of an API.

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