Pharmaceutical companyc Food and Drug Administration (FDA) has approved Zohydro ER (hydrocodone bitartrate) extended-release capsules.
Zohydro ER is 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.
Zohydro ER is the first extended-release formulation hydrocodone therapy without acetaminophen.
The use of products containing acetaminophen in high doses over long periods of time has the potential for causing liver injury.
Zogenix is committed to supporting appropriate use of opioid pain treatments for patients suffering from chronic pain.
The company will implement the risk evaluation and mitigation strategy (REMS) for ER and long acting (LA) opioids required by the FDA for all the products in the class.
In addition, Zogenix will participate in the design and implementation of post-marketing studies, as recently outlined by the FDA.
NDA sponsors of ER/LA opioids are now required to conduct studies to assess the serious risks associated with long-term use.
Zogenix president Dr Stephen Farr noted in addition to the REMS, Zogenix has voluntarily developed a series of safe use initiatives to support the appropriate use of Zohydro ER.
"As part of these initiatives, we will provide state-of-the-art integrated educational resources for patients, physicians and pharmacists and leverage surveillance programs to monitor for misuse and abuse.
Further, Zogenix has also started the development of an abuse deterrent formulation of Zohydro ER and we are committed to advancing the program as rapidly as possible," Farr added.
Zohydro ER capsules will be available in six dosage strengths ranging from 10-50mg with dosing every 12 hours.
Zohydro ER is classified as a Drug Enforcement Agency (DEA) Schedule II drug, making it subject to stricter prescribing and dispensing rules compared to the immediate-release hydrocodone-acetaminophen combination products, which are currently classified as Schedule III drugs.
On October 24, 2013, the FDA announced its intention to submit a formal recommendation to Health and Human Services by early December 2013 to reclassify hydrocodone combination products from DEA Schedule III to Schedule II, however, the date of implementation is currently unknown.
Zohydro ER was studied in over 1,100 people living with chronic pain who participated in the pivotal Phase 3 efficacy study or an open-label Phase 3 long-term safety study.
The efficacy study that enrolled over 500 subjects with chronic low back pain met the primary endpoint in demonstrating that treatment with Zohydro ER resulted in significantly improved chronic pain relief compared to placebo.
The key secondary endpoint was also achieved: a significantly higher number of subjects experienced at least 30% improvement in pain intensity from screening to end of study (67.5%, Zohydro ER versus 31.1%, placebo).
The safety profile of Zohydro ER in both Phase 3 studies was consistent with other opioids in that the most frequent treatment emergent adverse events were constipation, nausea, drowsiness (somnolence), fatigue, headache, dizziness, dry mouth, vomiting and itching (pruritus).
Zohydro ER uses Alkermes Pharma Ireland Limited's patented spheroidal oral drug absorption system (SODAS) drug delivery technology, which serves to enhance the release profile of hydrocodone to provide extended-release pain relief relative to existing immediate-release combination products.
