In April 2008, the Food and Drug Administration (FDA) approved Treximet® (sumatriptan / naproxen sodium) for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™.
This migraine medication works in two ways – the triptan component shrinks the swollen blood vessels in the head, which correlates to the relief of migraine pain, while the NSAID component inhibits the enzyme responsible for the production of prostaglandins, which are the mediators of pain and inflammation. As a result of this dual mechanism of action, Treximet has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components. The FDA approval was an important milestone for the partnership between the two companies. The partnership began in 2003, when GSK signed an agreement with POZEN for the development and commercialization of this product.
In May 2008, POZEN officially transferred the Investigational New Drug and New Drug Application for the product to GSK. GSK is responsible for the commercialization of Treximet in the United States. POZEN receiveds royalties based on net sales of Treximet from GSK at a rate of 18 percent. Treximet is available in U.S. pharmacies.
In November 2011, POZEN sold most of the future royalty and milestone payments covering Treximet sales in the United States to a financial investor for $75 million. By virtue of the agreement, the financial investor will be entitled to receive royalties on net sales of Treximet and any other products containing sumatriptan and naproxen sodium developed and sold by GSK under the collaboration and license agreement in the United States on or after October 1, 2011. POZEN retains rights to 20 percent of royalties paid on net sales of Treximet and such other products in the United States, beginning in the second quarter of 2018. POZEN has ex-U.S. rights to develop and market a lower dose sumatriptan and naproxen combination. This agreement has no effect on any future royalties from MT400 that might originate from sales of the product outside of the United States.
In August 2014, POZEN announced that the acquisition of all of GlaxoSmithKline’s (GSK) rights to Treximet® had been acquired by Pernix Therapeutics Holdings, Inc. (Pernix). As part of the divestiture, GSK has assigned the Product Development and Commercialization Agreement between POZEN and GSK to Pernix, and POZEN and Pernix have amended the agreement to address rights of the parties and future development. In addition, any restrictions on POZEN’s right to develop and commercialize additional certain dosage forms of sumatriptan / naproxen combinations outside of the United States have been eliminated, and POZEN may seek approval for these combinations on the basis of the approved U.S. New Drug Application.
For Full Prescribing Information, please visit www.Treximet.com.