MALTA, May 02, 2018 (GLOBE NEWSWIRE) — DRGT, a specialty pharmaceutical company with a proprietary formulation technology, announced the results of its successful dose escalation PK study for DRGT-99, an innovative formulation of tadalafil.
Tadalafil (Cialis®) was originally developed by Lilly ICOS, LLC –a longer lasting alternative to Sildenafil Citrate (Viagra®) and is indicated for the treatment of erectile dysfunction (ED) in adult males. Tadalafil is facing imminent patent expiration.
Whilst Cialis® is a long acting ED drug, its absorption shows extensive variability with Tmax values ranging from 0.5 h to 12 h for a single 20 mg tadalafil dose. Despite the recommendation on the label to take Cialis® 30 minutes before sexual activity, only a minority of the patients reported successful intercourse attempts 30 mins after taking the highest approved 20 mg dose of Cialis®. In the same study 10 mg Cialis® failed to achieve its end-point for successful intercourse attempts within 30 mins over the placebo group.
Following oral administration of DRGT-99 immediate release tablets, maximum drug concentration was achieved on average 4 times faster than with 20 mg Cialis®.
Administering the 10 mg or 15 mg DRGT-99 tablet, drug exposure was more than 3-fold greater and variability was lower than for 20 mg Cialis® in the first 30 mins.
Time to achieve therapeutically effective plasma levels was also significantly shorter for DRGT-99 than for 20 mg Cialis®. Around half of the subjects taking 10 mg DRGT-99 reached therapeutically effective plasma levels in 15 mins and 100% by 30 mins. This number for 15 mg DRGT-99 was 72% and 100% respectively. Even 5 mg DRGT-99 resulted in therapeutically effective plasma levels in 73% of the subjects at 30 mins.
As for 20 mg Cialis® none of the subjects reached therapeutically effective plasma levels in 15 mins and only half of them at 30 mins.
Furthermore, reported adverse events for DRGT-99 were less frequent and less severe for all the dosage strengths tested than for 20 mg Cialis®. A potential safety advantage for DRGT-99.
“Our objective with DRGT-99 has been to develop the Best in Class ED drug that combines reliable, fast onset, longevity and improved side effect profile at the lowest possible dose” – said Gabor Heltovics, CEO of DRGT. “These encouraging results indicate that we are on track to do just that. We are advancing DRGT-99 to pivotal studies”- he added.
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.
Cialis and Viagra are registered trademarks of their respective owners.