Conference: 2008 International PHA Conference and Scientific Sessions
Release Date: 06.20.2008
Presentation Type: Abstracts
White R.J.1, Allen R.2, Yehle D.3, Laliberte K. 3, Mottola D. 3, Galie N. 4, Simmoneau G. 5, Tapson V.F. 6
1. University of Rochester, Rochester, NY, USA
2. University of California at Davis, Sacramento, CA, USA
3. United Therapeutics Corp, RTP, NC, USA
4. University of Bologna, Bologna, Italy
5. Hopital Antoine Beclere, Clamart, France
6. Duke University Medical Center, Durham, NC, USA
BACKGROUND: Treprostinil (TRE) diethanolamine sustained release tablets (UT-15C SR) are currently being evaluated for the treatment of pulmonary arterial hypertension (PAH) in two Phase III trials. UT-15C is the diethanolamine salt of the prostacyclin analog, Remodulin® (treprostinil sodium). The pharmacokinetics (PK) of UT-15C SR have previously been reported in healthy volunteers at low doses (≤ 3 mg BID).
METHODS: During the open-label extension phase of the pivotal trials for UT-15C SR, we studied twelve patients who had received active drug for at least 4 weeks and at a stable dose (range 2-16 mg BID) for at least 5 days. Study patients had a trough sample collected, were administered UT-15C SR following a meal, and then had seven additional blood samples collected over 12 hours.
RESULTS: For these twelve patients (10F/2M; mean age 53 years; mean weight 85.5 kg), PK data are illustrated in the Figure. Plasma TRE concentrations achieved with UT-15C SR in this study relate favorably to a wide dosing range with parenteral Remodulin, with approximate Remodulin infusion doses indicated on the graph for comparison.
COMMENTS AND CONCLUSIONS: These preliminary data suggest that dosing with UT-15C SR provides sustained therapeutic TRE plasma concentrations over approximately 12 hours supporting BID dosing in patients with PAH.