Bryn declares patient preference for nasal spray over EpiPen

Mylan’s EpiPen (epinephrine) has been under sustained pressure since 2016, when the company’s behavior in raising the price of the product garnered attention from the US Congress​.

Following this, Mylan had to face a number of rivals seeking to have their generic products reach the market​, whilst also trying to manage dwindling stocks of its product after manufacturing issues led to shortages​.

Now, Mylan faces a new competitor with a product that takes aim at some of the potential weaknesses of the delivery system of the EpiPen.

Bryn Pharma’s investigational product is a bi-dose, epinephrine nasal spray, which is smaller than the rival EpiPen and can also be used twice, while EpiPen users are required to carry two pens.

The US Food and Drug Administration (FDA) has granted the product, BRYN-NDS1C, fast track designation for the treatment of anaphylaxis.

In order to support approval and potentially gain greater leverage, should it be approved, Bryn Pharma released data from a head-to-head study between its potential product and the EpiPen, judged on patient preference.

The study featured two groups of patients, one group that was labelled EpiPen-experienced and EpiPen-inexperienced – based on whether the patient had previously used an EpiPen or not.

The 56-patient study saw patients answer a questionnaire, where both groups answered in proportions of 75%+ with a preference for BRYN-NDS1C when asked on the likelihood of carrying the product in daily life and on which device was easier to use.

The same result was seen in preference on size of product, with 95.8% of EpiPen-experienced and 87.5% of EpiPen-inexperienced patients preferring the dimensions of BRYN-NDS1C. [Image of size comparison]

On the question of overall preference, the EpiPen-experienced group voted by 66.7% in favor of Bryn’s potential treatment and those in the EpiPen-inexperienced group were more confirmatory on the same question, with 84.4% preferring BRYN-NDS1C.

In the full publication of results​, the only question that received a negative reaction from participants was the question on whether an EpiPen or Bryn’s product would be used in an emergency, where the 66.7% of EpiPen-experienced patients suggested it was more likely to be the EpiPen – though the same reaction was not seen in EpiPen-inexperienced patients.

Earlier this month​, Bryn Pharma announced that it completed dosing in a pivotal trial for the product and would receive the results ‘shortly’.