Gallen Pharma has launched an innovative, more pleasant medical food — a protein substitute — in the U.K. for people with phenylketonuria (PKU), ages 8 and older.

The product, PKU Easy Microtabs, was originally developed by POA Pharma, a Swedish company recently acquired by Gallen.

While PKU Easy Microtabs have been available across Scandinavia since 2011, until now they were not accessible to U.K. patients through the National Health System.

“We are delighted to be able to bring this important new dietary management option to the 6,000 plus patients living with PKU across the UK,” Dennise Broderick, MD, Galen’s president and managing director, said in a press release.

PKU is an inherited disorder characterized by the body’s inability to break down phenylalanine, an essential amino acid — the building blocks of proteins — obtained from high-protein foods, including meat, fish, eggs, and nuts.

This metabolic deficiency results in the toxic buildup of phenylalanine throughout the body, leading mainly to brain damage.

There is no cure for PKU, which means that people with the disease require a lifetime of treatment. That includes a strict low-phenylalanine, or low-protein diet, and medical food such as artificial, phenylalanine-free protein substitutes. This diet allows people with PKU to obtain the amount of protein needed to support the body’s everyday functions.

Data from a recent U.S. survey showed that PKU treatment is associated with a high economic burden, with an average cost of $6,400 to $9,000 per year in medical foods alone.

However, amino acid-based protein substitutes and formulas often have an unpleasant taste and smell, as well as an unfriendly aftertaste, it has been shown.

Notably, a 2018 U.K. survey found that the unpleasantness of available medical food was one of the top three main reasons why both children and adults with PKU struggled to follow their prescribed diet.

PKU Easy Microtabs are innovative, small, coated tablets designed to overcome this challenge. The tablets have two distinct coatings. The first provides a “palatable taste experience” and prevents the tablet from dissolving before reaching the stomach, minimizing acid reflux and bad breath. The second coat allows a slow release of the food’s amino acids into the body.

These micro tablets can be swallowed with liquid or eaten with jam or fruit purée.

“We know from the community that many of the available options have an off-putting smell, taste bad and leave the patient with bad breath because of how they are digested,” said Simon Lawrence, commercial director of Galen Nordics, which had been POA Pharma.

“Today’s launch gives UK patients a more pleasant choice that other countries have already enjoyed the benefit of for years,” Lawrence added.

Broderick noted that people with PKU have to consider their nutrition choices daily to ensure they have the right levels of protein.

“Portability, taste and digestion of medical foods are all important considerations that we are proud to have addressed for the community with our novel microtabs,” she said.