Eton Pharma hit with FDA rejection for methanol poison treatment as regulator flags manufacturing concerns

Eton Pharmaceuticals’ dehydrated alcohol injection didn’t pass muster with the FDA, instead receiving a complete response letter (CRL) raising flags the company believes are “addressable.”

The issues noted in the CRL are mostly related to chemistry manufacturing and controls, according to a company release. Eton will now work on an action plan to address the FDA’s concerns.

“While we are disappointed with the FDA’s decision, our commercial business remains strong, and we are pleased that our momentum in product revenue growth has continued,” CEO Sean Brynjelsen said in the company’s statement.

He added however that Eton is “well positioned for continued sustainable long-term growth” thanks to a September acquisition of betaine anhydrous for oral solution that recently hit the market.

The injection was meant to treat methanol poisoning, which saw a spike in the U.S. after COVID-19 related hand sanitizer demand spread several contaminated products. The FDA in January accepted Eton’s application, which was previously given orphan drug designation, leading the company to expect seven years of exclusivity.

Other than betaine anhydrous for oral solution, which is used to treat rare amino acid processing disorder homocystinuria, Eton also offers Alkindi Sprinkle, or hydrocortisone oral granules, as a cortisol replacement therapy and a generic to rare ammonia disease treatment Carbaglu.

Eton previously received another CRL in 2019, denying its allergic conjunctivitis eye drop that it licensed to Bausch Health after submitting for approval. That letter was addressed to an unnamed partner of the company. The drops were approved the following year as Alaway Preservative Free.

The Illinois-based company brought in revenues of $5.3 million over this year’s first quarter in record sales and 144% quarter-over-quarter growth.

Elsewhere, Ascendis’ hormone replacement therapy recently saw an FDA snub as well for manufacturing reasons with the agency finding issues with the company’s manufacturing control strategy for variability of delivered doses.

Then of course there was Regeneron’s high-dose Eylea rejection, a surprise hit to the powerhouse eye drug that stunned analysts with extremely impressive efficacy results. That CRL was due to problems at a third-party drug filler, which the company is “committed to” working with the FDA and the filler to resolve. Similarly, the FDA recently posted a Form 483 against an Eli Lilly manufacturing site for filling line issues.