Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Prism Pharmaceuticals, an acute care specialty pharmaceutical company, has announced that the FDA has approved the new drug application for Nexterone injection, a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone intravenous.
Subscribe to our email newsletter
Prism intends to submit a supplemental new drug application (NDA) for the premixed configurations which will form the focus of the commercial launch of Nexterone as a complete product line.
Prism is currently implementing a full scale manufacturing development program with the medication delivery business of Baxter Healthcare, a developer of premix technologies.
The FDA approval of Nexterone triggers a second $10 million milestone payment from Paul Capital. This long range financing agreement, established in September 2006, provides Prism with non-dilutive capital to enable the company to bring Nexterone through the period of NDA review and commercial launch.
Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.
Warren Cooper, president and CEO of Prism, said: “We developed Nexterone to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias.”