The Food and Drug Administration (FDA) has approved Natpara (parathyroid hormone; NPS Pharmaceuticals) for injection as adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism.
Natpara is a bioengineered replica of human parathyroid hormone. Parathyroid hormone raises serum calcium by increasing renal tubular calcium reabsorption, increasing intestinal calcium absorption (eg, by converting 25 OH vitamin D to 1,25 OH2 vitamin D) and by increasing bone turnover which releases calcium into the circulation.
The safety and efficacy of Natpara was studied in a trial (n=124) to determine if Natpara can be used as a substitute for, or be used to help reduce the amount of, active vitamin D or oral calcium taken by the patients. Study results showed 42% of patients treated with Natpara achieved normal blood calcium levels on reduced doses of calcium supplements and active forms of vitamin D vs. 3% of patients treated with placebo.
Natpara injection will be available as a medication cartridge comprised of a multi-dose, dual-chamber glass cartridge containing lyophilized powder and a diluent. The medication cartridge is available in 25mcg, 50mcg, 75mcg, and 100mcg/dose strengths in 2-count packages. It is intended for use with 31G x 8mm BD Ultra-Fine Pen needles.
Natpara is anticipated to launch in the second quarter of 2015 through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
For more information call (855) NAT-PARA or visit NPSP.com.