Boston, MA 03/18/2014 (wallstreetpr) – Zogenix, Inc. (NASDAQ:ZGNX) may be heading for a big trouble as a clamor is growing for withdrawal of its powerful new painkiller Zohydro. The drug hit the headlines in 2013 when Zohydro it became the first all-hydrocodone pain reliever ever cleared by the USFD which also made it the first approved pure opiate. But as more and more people came to know about its addictive side its opposition has become stronger. A major point against this drug is that like other highly addictive opioid pills it has been designed to release a drug over time. It makes it easier for the drug abusers to crush and snort it for a stronger, faster high. The FDA had approved the drug despite the 11-2 vote in the advisory panel against Zohydro.
Very recently FDA Commissioner Margaret Hamburg was summoned by the U.S. Senate’s Health, Education, Labor and Pensions Committee for a hearing related to the matter. In her testimony before the panel Ms. Hamburg admitted that USFDA knows that Zohydra is a powerful drug, but the regulatory authority approved the drug with a view that if appropriately used, it may be an important and unique tool for pain management which also meets the standards for safety and efficacy.
Following the hearing of Ms. Hamburg, a Bill was introduced by Senator Joe Manchin (D-WV) that stipulates to force the FDA to withdraw Zohydro from the market. The Bill also contains features which will prohibit any future approvals of painkillers not having tamper-resistant features. A similar law has been introduced in the House as well.
Zogenix, Inc. (NASDAQ:ZGNX) is now trying to calm the anti-drug abuse lobby by offering “complimentary access to locking pill caps,” which requires a combination to open. The company is also working to develop two “abuse deterrent formulations” that may hit the market by the October 16.
The battle to save Zohydro’s approval may be vital for Zogenix, Inc. (NASDAQ:ZGNX) as its Q4 results in FY 13 reported total revenues for quarter 2013 at $9.9 million, slightly up from $9.5 million in the Q4 of FY12. If Zohydro’s approval is overturned the company may struggle to keep its revenue steady.
Zogenix, Inc. (NASDAQ:ZGNX) may be heading for a big trouble as a clamor is growing for withdrawal of its powerful new painkiller Zohydro. The drug hit the headlines in 2013 when Zohydro it became the first all-hydrocodone pain reliever ever cleared by the USFD which also made it the first approved pure opiate. But as more and more people came to know about its addictive side its opposition has become stronger. A major point against this drug is that like other highly addictive opioid pills it has been designed to release a drug over time. It makes it easier for the drug abusers to crush and snort it for a stronger, faster high. The FDA had approved the drug despite the 11-2 vote in the advisory panel against Zohydro.
Very recently FDA Commissioner Margaret Hamburg was summoned by the U.S. Senate’s Health, Education, Labor and Pensions Committee for a hearing related to the matter. In her testimony before the panel Ms. Hamburg admitted that USFDA knows that Zohydra is a powerful drug, but the regulatory authority approved the drug with a view that if appropriately used, it may be an important and unique tool for pain management which also meets the standards for safety and efficacy.
Following the hearing of Ms. Hamburg, a Bill was introduced by Senator Joe Manchin (D-WV) that stipulates to force the FDA to withdraw Zohydro from the market. The Bill also contains features which will prohibit any future approvals of painkillers not having tamper-resistant features. A similar law has been introduced in the House as well.
Zogenix, Inc. (NASDAQ:ZGNX) is now trying to calm the anti-drug abuse lobby by offering “complimentary access to locking pill caps,” which requires a combination to open. The company is also working to develop two “abuse deterrent formulations” that may hit the market by the October 16.
The battle to save Zohydro’s approval may be vital for Zogenix, Inc. (NASDAQ:ZGNX) as its Q4 results in FY 13 reported total revenues for quarter 2013 at $9.9 million, slightly up from $9.5 million in the Q4 of FY12. If Zohydro’s approval is overturned the company may struggle to keep its revenue steady.
