Pernix' share rise as FDA approves Treximet for pediatric use

The US Food and Drug Administration has approved Pernix Therapeutics’ (Nasdaq: PTX) Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.The news pushed the firm’s share up 7% to $6.91 in afternoon trading on Friday.

Treximet is the first approved combination prescription medicine, and the first to contain sumatriptan, for the treatment of acute migraine attacks in pediatric patients. The two medicines – sumatriptan and naproxen sodium – in combination provide more effective, sustained control of the pain and associated symptoms of migraine compared to either medicine taken alone.

Pernix acquired US rights to Treximet from UK pharma major GlaxoSmithKline (LSE: GSK) a year ago, in a deal that cost it $250 million upfront and an agreement to pay royalties of 18% on future sales (The Pharma Letter May 15, 2015). GSK’s Treximet net US sales in 2013 were $78.7 million. In the first quarter of this year, Treximet revenues were $21 million out of total sales of $33.9 million, but the company forecast total sales in 2015 would be between $220 and $250 million, with revised expectations for Treximet, and with important investments in the Zohydro ER franchise