People prescribed Remodulin may soon have another way to take the medication. Pharmaceutical manufacturer United Therapeutics, maker of treprostinil sodium (Remodulin) for pulmonary hypertension, has signed an agreement with Aradigm, a California-based drug delivery systems developer, to produce an inhaled form of Remodulin.
The two companies made the announcement October 24.
Novel Delivery Method in Development
The deal, described as a development and commercialization agreement, will focus on the development of a sustained release, liposomal form of Remodulin using Aradigm's proprietary AERx System.
"We believe patients affected by pulmonary hypertension will be enthusiastic about a convenient, non-invasive inhaled treatment," said Stephen Farr, PhD, Aradigm's Senior Vice-President and Chief Scientific Officer, in a statement. "This agreement follows a positive in-vitro feasibility assessment of AERx aerosolized treprostinil, and builds on our internal experience in the development of novel liposomal formulations of proven drugs."
Liposomal medications involve encapsulating the drug in globules of fat to help increase absorption of the drug.
Early on, Aradigm will be responsible for the development and preclinical testing of the new form of Remodulin. Using the company's proprietary delivery system, it's hoped that the medication will target the deep lung as a systemic therapy for pulmonary arterial hypertension.
Few Doses Required?
Remodulin is currently available as a continuous injection, either subcutaneously or intravenously using a special pump. Using the inhaled form of the drug, patients will be required to take it only once or twice per day, the two companies stated.
"We are pleased to be collaborating with Aradigm, and leveraging their technology and extensive formulation expertise to develop a liposomal treprostinil product for once or twice-a-day inhalation," said Roger Jeffs, PhD, President and CEO of United Therapeutics, in a statement. "We were pleased with previous evaluations of AERx to deliver treprostinil, and we are excited at the potential of this product to build up TRIUMPH, the ongoing inhalation program being developed by our subsidiary, Lung, Rx."
TRIUMPH is a Phase 2 clinical trial designed to test the safety and efficacy of inhaled Remodulin. Investigators in the planned double-blind, placebo-controlled trial are currently recruiting patients. The study began this past summer.1
Added Farr: "The combination of the accurate deep lung delivery capabilities of the AERx system and a liposomal formulation of treprostinil designed for pulmonary delivery will allow for an infrequent inhalation regimen of a proven and efficacious compound."
1. Clinical investigation into the efficacy and tolerability of inhaled treprostinil sodium in patients with severe PAH. Available at: http://clinicaltrials.gov/ct/show/NCT00147199?order=3. Accessed October 28, 2005.
John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include overseeing health news coverage for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.
