DRGT's novel Celecoxib composition - opportunity for low dose, immediate onset of pain relief with the only NSAID COX-2 inhibitor on the market

SWATAR, MALTA--(Marketwired - Dec. 19, 2016) - DRGT, a specialty pharmaceutical company announced today the Phase I clinical results of its DRGT-46 and DRGT-47 programs, new compositions of Celecoxib – a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).

There are many treatment options for pain. Traditional NSAIDs (e.g.; ibuprofen, naproxen) are nonselective – they inhibit both COX-1 and COX-2. The inhibition of COX-2 accounts for pain relief and anti-inflammatory effects, whilst the inhibition of COX-1 can lead to toxicity and associated side effects (ulcers, prolonged bleeding time, kidney problems). Celecoxib is the only COX-2 inhibitor on the market. It is used to treat pain and inflammation, however its use in pain management is limited by a long "kick in" time as a pain killer (50 mins – 1.5 hours) even at the highest (400mg) dose.

DRGT-46 (200 mg) and DRGT-47 (100 mg), novel Super-API compositions were developed by DRGT as new fast and flexible treatment options for acute and chronic pain.

In a Phase 1 clinical study DRGT-46 and DRGT-47 showed very rapid absorption and the opportunity for immediate pain relief. The published effective concentration for onset of action (Ceff =250 ng/ml) was reached within 12 minutes at both doses (100 and 200 mg); under both fasted and fed (high fat) conditions.

"We are very pleased with this result. It has the potential to offer important improvements in pain medication. It is now possible to treat pain effectively and immediately at the lowest possible dose with the only NSAID COX-2 inhibitor on the market." – said Gabor Heltovics, CEO.

About DRGT

DRGT is a specialty pharmaceutical company dedicated to the development and commercialization of high-value proprietary drugs that deliver measurable and meaningful improvements in clinical utility.

DRGT utilizes its proprietary Super-API drug development platform to carefully select and screen drugs and develop their Super-API compositions. The Company's Super-API portfolio contains 30 compounds in indications such as oncology, pain and erectile dysfunction with multi-$ billion potential. Super-API drugs are protected by global composition of matter IP.

DRGT is incorporated in Ireland with R&D facilities in Budapest, Hungary.

The corporation was founded by Dr. Ferenc Darvas, Chairman of the oldest Hungarian upstream-technology network.