Zogenix Inc. (ZGNX) has traded like a company that is about to implode. Its highly controversial Zohydro has been getting inquiries into how it was approved for marketing despite an FDA panel being against the recommendation. As this is said to be one of the strongest and perhaps most addictive pain medicines, the company's shares have fallen sharply from its highs.
Late Friday came a letter to shareholders from Zogenix CEO Roger Hawley. The letter said that reports about Zohydro have been false and misleading and that Zohydro is the first and only approved extended release hydrocodone product without acetaminophen.
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Hawley told shareholders:
This misinformation has created negative perceptions about Zohydro ER, which was approved by the FDA in October 2013 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. Up to 2.4 million patients who are currently taking immediate-release hydrocodone with acetaminophen for management of their severe chronic pain may be at risk for liver damage due to acetaminophen, which can be fatal or require a liver transplant. Zohydro ER serves as an important option for those patients, as well as providing an alternative option for severe chronic pain patients who have developed opioid tolerance, are not getting optimum pain relief or are experiencing side effects with other long-acting opioids.
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He goes on to discuss what the company is doing differently and what it hopes for, including a denial that it acted improperly:
We further would like to note that without justification, inaccurate allegations have been made that Zogenix paid a university to arrange meetings with the FDA to secure approval of Zohydro ER. The university in question has declared for the record that, in the meetings it arranged with FDA officials, no representation from Zogenix was present, nor was the company or its products ever discussed. In fact, Zogenix did not even exist as a company at the time of these meetings.
Details of the full letter are here.
Zogenix shares were down another 3.5% in late Friday trading, against a 52-week range of $1.25 to $5.19. The company's market cap was $457 million on last look.
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