u-62840 and Peripheral-Vascular-Diseases

United Therapeutics Corp (UTC) is developing treprostinil sodium (Remodulin, UT-15), a stable structural analog of prostacyclin, for the potential treatment of primary pulmonary (arterial) hypertension (PAH), peripheral vascular disease (PVD) and other cardiovascular conditions [327593], including critical limb ischemia (CLI) [412483]. In August 2000, UTC submitted the initial, non-clinical sections of an NDA for the treatment of pulmonary hypertension [378906]. Treprostinil, which had previously been designated as an Orphan Drug, was also awarded Priority Review status by the US FDA in October 2000 [385864], [386271]. In December 2000, UTC agreed with the FDA that the NDA for treprostinil did not need to be presented to the Cardiovascular and Renal Drugs Advisory Committee, which was expected to allow UTC and the FDA to work towards the 6-month Priority Review timeline [393888]. On August 9, 2001, the advisory committee recommended approval of treprostinil and UTC refiled the NDA on the same day [418682]. In February 2002, the FDA issued an approvable letter for treprostinil injection for the treatment of PAH. The FDA proposed drug labeling for PAH consistent with the treatment of both primary and secondary pulmonary hypertension in patients with New York Heart Association (NYHA) Class II-IV symptoms. The approvable letter also stated that the FDA intended to approve treprostinil with a requirement that UTC subsequently conduct a post-marketing controlled clinical trial to verify and further describe the drug's clinical benefit [439278]. In February 2001, UTC submitted a marketing authorization application (MAA) in France for approval of treprostinil for the treatment of PAH. Upon approval of the MAA, UTC planned to file for Mutual Recognition in other European countries and was also preparing similar submissions to non-European countries [391986], [397958]. By early 2001, phase II trials of treprostinil for the treatment of CLI were underway [412483]. In March 2001, the company was planning a phase III pivotal study in late-stage PVD by the end of 2001 [424180]. In April 2000, UTC was issued US-06054486 for the method of treating PVD with treprostinil [364130]. In February 2000, UTC entered into an agreement with Paladin Labs for the exclusive Canadian distribution of treprostinil for the remainder of clinical trials and after regulatory approvals [357302]. In November 2000, UTC and Antigen Pharmaceuticals entered into a strategic alliance for the distr

Topics: Cardiovascular Agents; Clinical Trials as Topic; Epoprostenol; Extremities; Humans; Hypertension, Pulmonary; Ischemia; Peripheral Vascular Diseases; Platelet Aggregation Inhibitors

Impaired healing of saphenous vein harvest sites is a serious but under-recognized complication of coronary artery bypass grafting surgery, particularly in the presence of peripheral arterial disease. We report the use of a continuous subcutaneous infusion of treprostinil sodium, an analog of prostacyclin, to treat a limb-threatening, nonhealing saphenous vein harvest incision site after myocardial revascularization.

Topics: Aged; Arterial Occlusive Diseases; Coronary Artery Bypass; Coronary Disease; Epoprostenol; Humans; Infusions, Intravenous; Injections, Subcutaneous; Male; Peripheral Vascular Diseases; Postoperative Complications; Risk Assessment; Saphenous Vein; Tissue and Organ Harvesting; Treatment Outcome; Wound Healing; Wounds and Injuries