Zohydro ER (hydrocodone bitartrate extended release) / Currax - LARVOL DELTA

Painful decision-making at FDA (Expert Opin Drug Saf) - "Additionally, the rewording of the labeled indication (from 'moderate to severe pain' to 'severe enough pain') for extended-release opioid analgesics, in an attempt to provide clarity, resulted in an equally if not more vague statement of appropriate use. Furthermore, the postmarketing requirement for continued data regarding safety and efficacy have been affirmed by FDA but some of the proposed means to acquire those data will likely result in unclear answers and may have undesired consequences."

Review • Pain

Relative Intranasal Abuse Potential of Hydrocodone ER (AAPMgmt 2016) - "Intact oral hydrocodone ER liking scores were similar to those of placebo. Drug liking measures reflected the observed pharmacokinetics."

Clinical • Biosimilar • Demo Pain • Pain

US bill would force FDA to withdraw approval of new pain drug Zohydro (Br Med J) - Abstract not available.

Regulatory • Pain

Zogenix statement: Let's get the facts straight about Zohydro ER (PRNewswire) - "Zohydro ER is the same hydrocodone currently available in a number of combination products, but without acetaminophen. In fact, in terms of hydrocodone potency, a 10 mg dose of Zohydro ER is actually the exact same potency as a 10 mg dose of Vicodin or any other hydrocodone product....Zogenix is also compensating our product representatives not on sales volume of Zohydro ER, but rather on their efforts to ensure prescribers, pharmacists and patients are educated to understand the risks and benefits of using extended-release opioids."

Review • Pain

Zogenix reports fourth quarter and full year 2013 financial results (GlobeNewswire) - "Roger Hawley, chief executive officer of Zogenix, stated, '...This week, we made Zohydro ER available through select pharmacies and we've commenced our educational efforts with prescribers and pharmacists.' "

Commercial • Pain

Zogenix - Is there enough upside for Zogenix? (SeekingAlpha) - "Peak annual revenue in a good scenario after 3 years could be $200MM ($50MM for Sumavel and $150MM for Zohydro)."

Sales projection • Pain

FDA is urged to reverse its approval of new pain drug Zohydro ER (Br Med J) - Abstract not available.

Regulatory • Pain

Orange Book: Approved drug products with therapeutic equivalence evaluations: Newly added patent (FDA) - Newly added patent in Orange Book for hydrocodone bitartrate.

Patent • Pain

Lawyers for Zohydro maker urge judge to strike down Mass. restrictions (The Boston Globe) - "Lawyers for Zogenix...urged a federal judge today to strike down the state’s restrictions on the drug....Jo Ann Shotwell Kaplan, an assistant state attorney general, said the state was clearly targeting Zohydro, but she said doctors have also agreed – and signed affidavits to that effect – that they would still prescribe Zohydro if necessary."

Corporate lawsuit • Pain

Zogenix provides business update (GlobeNewswire) - "Total prescriptions for Zohydro ER in the fourth quarter 2014 were approximately 19,000, a 26% increase compared to the third quarter 2014."

Commercial • Pain

Drug approval briefs: Cubist, Iroko, Merck Serono, UCB, Genentech, Allergan, GE Healthcare, Zogenix (Pink Sheet - Informa) - “Iroko Pharmaceuticals LLC’s small-particle diclofenac formulation Zorvolex won FDA approval for treatment of mild to moderate acute pain in adults...Zogenix Inc.’s Zohydro ER cleared FDA Oct. 25 for the management of pain...”

NDA • Pain

Long-term study of hydrocodone bitartrate controlled-release capsules in subjects with chronic pain (clinicaltrials.gov) - P3, N=424; Active, not recruiting -> Completed

Trial completion • Pain

Zogenix reports fourth quarter and full year 2012 financial results (Zogenix) - "We continue to move forward with launch preparations for Zohydro ER while we wait for further communication from the FDA on the NDA...If approved, we anticipate launching the product three to four months after approval."

Anticipated launch US • Pain

Zogenix announces closing of public offering of common stock, including full exercise of over-allotment option by underwriters (Zogenix Press Release) - "Zogenix intends to use the net proceeds from the offering to fund pre-commercialization and commercialization activities for ZohydroTM ER, additional development activities of Zohydro ER and ReldayTM, and for working capital and other general corporate purposes. Zogenix may also use a portion of the net proceeds to in-license, acquire or invest in complementary businesses or products."

Financing • Pain

Relationship between change in pain intensity and functional outcomes in patients with chronic pain receiving twice daily extended-release hydrocodone bitartrate. (PubMed) - J Opioid Manag - "Moderate or substantial levels of pain relief were associated with the greatest functional improvements in patients treated with HC-ER. These results may help define success of opioid therapy and determine if it should be continued or an alternative treatment should be tried."

Journal • Biosimilar • Depression • Pain

Zogenix provides update on Zohydro ER regulatory review (Zogenix) - "Zogenix...announced that it has been informed by the U.S. Food and Drug Administration (FDA) that Zogenix is unlikely to receive an action letter for its New Drug Application (NDA) for ZohydroTM ER (hydrocodone bitartrate extended-release capsules) by the Prescription Drug User Fee Act (PDUFA) goal date of March 1, 2013. Under the performance goals set by the FDA under PDUFA, the agency can miss the prescribed goal date for approximately ten percent of the NDAs..."

NDA • Pain

Q3 2012 Results (Zogenix) - PDUFA date for pain on March 01, 2013; Anticipated approval for pain in March 2013; Anticipated launch for pain in Q2 2013; Anticipated FDA Advisory Committee meeting on December 07, 2012

Anticipated FDA event • Anticipated launch US • PDUFA date • Pain

Zogenix: Investor Presentation (Zogenix) - "Phase 3 Efficacy Study (Study 801) Met Endpoints"; "Significant difference in chronic pain relief,Zohydro ER vs. placebo (p=0.008) based on average mean changes in daily pain intensity (Numeric Rating Scale)"; "Key secondary endpoints support Zohydro ER efficacy – Responder Rate Analysis: Significantly higher proportion of patients (%) experiencing improvement in pain relief from beginning to end of study"

P3 data • Pain

Pernix Therapeutics: Q4 & FY 2015 Results (Pernix Therapeutics) - Anticipated extension of two new Orange Book patents through 2034

Anticipated patent expiry • Pain

Single-entity hydrocodone extended-release for chronic pain (PAINWeek 2012) - P3, N=424; NCT01115569; Changes in BPI scores from screening to end of treatment showed improvement in pain severity, relief achieved with medication, and interference with activities; HC-ER exhibited a safety profile consistent with that of other opioids and appeared effective for managing chronic pain

P3 data • Pain

Pharmacokinetic Profile and Sustained 24-hour Analgesia of a Once-daily Hydrocodone Bitartrate Extended-release Tablet with Abuse-deterrent Properties. (PubMed) - Clin Ther - "Once-daily HYD exhibits linear, dose-proportional PK properties and is associated with a lower variability in plasma hydrocodone concentrations when compared with an immediate-release hydrocodone combination product. Notably, analgesia provided by HYD is sustained during the 24-hour dosing interval. ClinicalTrials.gov identifier: NCT01400139 (Study 4)."

Journal • Biosimilar • Pain

Zogenix submits new drug application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro for treatment of chronic pain (PRNewswire) - First NDA submission for an extended-release hydrocodone therapy without acetaminophen; In conjunction with Zohydro's NDA submission, Zogenix is required to make a milestone payment of $1.0 million to Alkermes Pharma Ireland Limited

NDA submission • Pipeline shift • Pain

Pernix: Q2 2015 Results (Pernix Therapeutics) - Anticipated patent expiry in 2029

Anticipated patent expiry • Pain

Zogenix receives FDA approval for Zohydro ER (hydrocodone bitartrate) extended-release capsules (Zogenix Press Release) - "Zogenix...today announced that the U.S. Food and Drug Administration (FDA) has approved ZohydroTM ER (hydrocodone bitartrate) extended-release capsules, an opioid agonist, extended-release oral formulation of hydrocodone without acetaminophen, 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. Zogenix expects to launch Zohydro ER in approximately four months."

Anticipated launch US • NDA • Pain

Conference Call (Zogenix) - PDUFA date for pain on March 01, 2013

PDUFA date • Pain