Pernix Therapeutics Holdings Inc (NASDAQ:PTX), a specialty pharmaceutical company, today announced that a series of studies of ZX007, the Company’s next-generation extended release formulation of hydrocodone bitartrate developed in coordination with Altus Formulation, showed the tablet resists both physical manipulation and extraction with typical household solvents commonly used by opioid abusers. The success of the studies supports continued evaluation of the formulation in human abuse liability (HAL) studies. The analysis was accepted as a late-breaking abstract and will be presented as a poster at PAINWeek, the nation’s largest pain conference for frontline practitioners taking place this week in Las Vegas.
“The studies were performed using common methods that may be undertaken by opioid abusers to manipulate a controlled release product, as well as ways in which a patient may alter the formulation,” said Damon Smith, CEO of Altus Formulation. “In vitro studies of ZX007 demonstrated that the formulation resisted attempts at manipulation and extraction in a wide range of solvents and maintained a controlled release after crushing and grinding.”
Studies included attempts to crush tablets using a variety of methods and extraction tests utilizing cold or boiling water, low and high pH media, alcohol, methanol, nail varnish remover and isopropyl alcohol. Manipulation with water and other solvents resulted in the immediate formation of a viscous gel with no supernatant or aqueous extraction solution being formed.
“We are pleased with the promising outcome of these studies. Pernix is committed to introducing abuse-deterrent formulations of hydrocodone to promote the safe use of our products and for the benefit of patients who would otherwise have to endure severe pain,” said Doug Drysdale, President, Chairman and CEO of Pernix. “Our aim is to bring this new treatment option to market responsibly, focusing on the patients and helping to reduce the overall burden of opioid misuse and abuse.”
Pernix markets Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek™, which is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Zohydro ER does not contain acetaminophen, unlike many immediate-release hydrocodone products, reducing the risk for potential liver toxicity due to overexposure of acetaminophen. Zohydro ER with BeadTek is available in strengths 10 mg, 15 mg, 20 mg, 30 mg, 40 mg and 50 mg.
ZX007 is being developed using INTELLILAB™ technology, an innovation of Altus Formulation Inc. (Original Source)
Shares of Pernix Therapeutics closed yesterday at $4.61. PTX has a 1-year high of $12.88 and a 1-year low of $4.25. The stock’s 50-day moving average is $4.85 and its 200-day moving average is $7.06.
On the ratings front, Pernix has been the subject of a number of recent research reports. In a report issued on September 3, Brean Murray Carret analyst Difei Yang maintained a Buy rating on PTX, with a price target of $14, which implies an upside of 203.7% from current levels. Separately, on July 28, Oppenheimer’s Akiva Felt reiterated a Buy rating on the stock and has a price target of $13.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Akiva Felt have a total average return of 11.3% and 31.8% respectively. Yang has a success rate of 48.9% and is ranked #416 out of 3752 analysts, while Felt has a success rate of 57.1% and is ranked #29.
Pernix Therapeutics Holdings Inc is a specialty pharmaceutical company focused on the sales, marketing and development of branded and generic pharmaceutical products for sleep, bacterial infections and cough and cold conditions.