RIDGELAND, Miss.--(BUSINESS WIRE)--Wraser Pharmaceuticals, LLC, a specialty pharmaceutical company, today announced that it has received FDA Approval on Trezix™ (acetaminophen / caffeine / dihydrocodeine bitartrate) Capsules, CIII.
Heath Wray, President of Wraser Pharmaceuticals noted, “The approval of Trezix™ allows Wraser to continue its commitment to the pain management space and also adds a unique product to the market, as an alternative to hydrocodone containing products.” The recent announcement from the DEA regarding the upsechedule of hydrocodone combination products to a Schedule II is also expected to drastically impact the sales of Trezix™ which will remain a Schedule III.
Wraser plans to launch Trezix™ no later than December 15th, 2014 and will focus on previous supporting healthcare professionals as a Phase I approach. Wraser will also look to increase the presence of Trezix™ by expanding its current organic sales force and by seeking strategic co-promote partnerships. Trezix™ is also available immediately under our exclusive mail-prescription program called SAVER EXPRESS™. If healthcare providers elect to use this simple program immediately, they can visit the Trezix™ website at www.trezixrx.com to learn more.
Important Safety Information about Trezix®
Prescription Trezix™ capsules are indicated for the relief of moderate to moderately severe pain. Trezix™ contains acetaminophen. Increased doses of acetaminophen have been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen containing product.
Trezix™ is contraindicated in patients with hypersensitivity to dihydrocodeine, codeine, acetaminophen, caffeine, or any other inactive components in Trezix™, or any situation where opioids are contraindicated including significant respiratory depression (in unmonitored settings or in the absence of resuscitative equipment), acute or severe bronchial asthma or hypercapnia, and paralytic ileus.
Healthcare providers, pharmacies, wholesalers, and patients are encouraged to visit the website for Trezix™ at www.trezixrx.com.