The company is aiming to license out the technology for specified territories, whilst maintaining the intellectual property.
Most patients who have this disorder are required to maintain a life long intake of sodium phenylbutyrate therapy up to 12 grams a day. However, the compound is extremely bitter in taste and daily dose is very high, presenting an unusually difficult taste-masking challenge.
ForTe's product is a proportional formulation suitable for administration of the full range of required dosages to children and adults. It takes the form of a high drug load reconstitutable powder mixture for solutions, so patients can mix up the dose and drink it. At present, the requirement is for patients to take up to 20 tablets a day, so ForTe believes this new formulation will help improve patient compliance with therapy.
The formulation does not contain sugar or preservatives and can be a single dose powder packed in sachet or multi dose powder packed in a container, notes ForTe.
These nitrogen elimination or 'urea cycle' disorders are relatively rare, affecting only 1 in 10,000 births, but the consequences of poor compliance can be dramatic. One of the effects of accumulating nitrogen in the body is that it can get into the central nervous system and cause brain damage and death if not diagnosed at birth.
However, ForTe notes that the dry powder technology used in the product is compatible with a broad range of active ingredients used in human pharmaceutical and over-the-counter (OTC) products.
For more information on ForTe and the formulation technology, visit the company's website or e-mail meijlink@forte-bv.nl.