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SOURCE: Jet Life Penny Stocks
http://www.jetlifepennystocks.com Newsletter Announces Alert On Our Past Awesome Penny Stock Pick Zogenix Inc.
Stamford, CT (PRWEB) October 04, 2012
Zogenix Inc. is a pharmaceutical stock that the Jet Life Penny Stocks team has followed for most of this year, and wants to inform investors of once again.
Jet Life informed investors of Zogenix on the company website in July, when the stock price was $2.30 per share. Even with the recent run to $3.14, there is still significant upside potential in the stock from here, as investors await comments from the FDA advisory committee on Zohydro ER, and as the PDUFA date approaches in March.
On July 16, 2012 Zogenix announced FDA acceptance for review of the NDA for Zohydro ER, an extended release version of hydrocodone, the active ingredient opposite acetaminophen, in the prescription pain medication Vicodin. The goal for a standard review of an NDA is 10 months from NDA submission, and the FDA has assigned a target action date of March 1, 2013 for the Zohydro ER NDA.
The reason investors have continued to push the stock upward recently, is likely a result of Zohydro ER’s chances for approval being slightly higher than that of most pain medication NDA’s. There is no discounting risk associated with FDA Drug Approval plays, but Zohydro ER has a few positives in its back-pocket upon this FDA review.
The reasons Zohydro ER could be approved by the FDA are as follows:
•The active ingredient in Zohydro ER, hydrocodone, has been used in the treatment of pain for many years. It is not a new molecule/compound for the FDA or physicians to understand, as demonstrated by the millions of prescriptions filled each year for hydrocodone containing products. 131 million prescriptions were written for generic Vicodin (hydrocodone/acetaminophen) in 2011.
•Zohydro ER demonstrated strong results in clinical trials: “Study 801 successfully met its primary efficacy endpoint, demonstrating that Zohydro ER resulted in significantly (p=0.008) improved chronic pain relief compared to placebo,” and side-effects were “consistent with those typically seen with chronic opioid therapy“. In other words, patients had effective pain relief, and experienced no more side-effects than with other common chronic-opioid drugs.
If approved, there are several reasons why Zohydro ER can potentially build a niche in the massive prescription drug pain market:
•Zohydro would be the only non-acetaminophen (non-liver toxic) hydrocodone pain alternative on the market. This is important fact, because generic (cheap) alternative hydrocodone products currently on the market, all contain acetaminophen.
•Zohydro ER would also be the first 12 hour formulation for hydrocodone on the market compared the 4-6 hour formulations. This should decrease medications adherence issues for patients and help effectively treat pain.
•Zohydro ER will be classified as a Schedule II drug, but in terms of perception with physicians, it may be viewed by physicians as a chance to treat pain without prescribing what are traditionally considered the ‘heavy-hitter’ narcotic drugs most subject for abuse. 12 Hour
Zohydro ER would offer physicians the chance to prescribe a non-oxycodone, non-morphine, non-hydromorphone pain alternative, in addition to avoiding the acetaminophen liver issues.
The FDA will convene an advisory committee for Zohydro ER during the current PDUFA review period. The advisory committee provides the FDA with independent expert advice and recommendations; however, the final decision regarding approval is made by the FDA.If the advisory committee is supportive of the approval of Zohydro ER, it would serve as a strong sign that the drug may be approved, and Zogenix stock could likely see much higher highs than the $3.14 range.
About Jet Life Penny Stocks
The team focuses on keeping investors informed of the top penny stocks and sectors. To receive their penny stock newsletter, please visit the company website at http://www.jetlifepennystocks.com.
Disclosure: Jet Life Penny Stocks is not a registered securities advisor. Investors should always conduct their own additional due diligence with any potential investment or highlighted company. The company provides information on highlighted stocks via press releases, newsletters and company website, but this should not be construed as a recommendation to buy or sell. Please visit the company website for a more complete list of risks and disclosures.
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