Zogenix (ZGNX) needed some good news after the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) voted 11 to 2 against recommending the approval of Zohydro (hydrocodone), a pain killing drug that can be 10 times stronger than Vicodin. While the AADPAC vote is not binding on the FDA, most analysts agree that there is little hope the agency will approve the vote when the agency is scheduled to complete their review of the drug in March 2012. (More comprehensive coverage on Zohydro can be found here).
Zogenix got a bit of good news on January 3, 2013, when the company announced positive single-dose pharmacokinetic results from the Phase 1 clinical trial of Relday (risperidone), an investigational once-monthly subcutaneous schizophrenia treatment.
Adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products.
Based on the favorable safety and pharmacokinetic profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the current study to include a 100 mg dose of the same formulation. The addition of this dose arm to the study will enable the company to evaluate dose proportionality across the full dose range that would be anticipated to be used in clinical practice.
Positive results from this study extension would better position Zogenix to begin a multi-dose clinical trial, which would provide the required steady-state pharmacokinetic and safety data prior to initiating Phase 3 development studies.
Zogenix expects to complete the extension of the Phase 1 clinical trial during the second quarter of 2013.
With these favorable results, Zogenix can begin discussions with potential partners for the development and commercialization of Relday. Since this approach involves selecting the dose by administering different volumes of the same formulation by a healthcare professional, the development of Relday will first focus on delivery by conventional needle and syringe while accelerating the overall program timeline. The introduction of the DosePro needle-free technology can occur later in development or as part of life cycle management after further work involving formulation development, technology enhancements, and applicable regulatory approvals.
Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia in adults and teenagers 13 years of age and older. The global long-acting injectable antipsychotic market was approximately $2 billion in 2011. The leading injectable product in the category requires twice-a-month dosing, intramuscular injection and drug reconstitution prior to use. The combined market for oral and injectable antipsychotic products was estimated at more than $17 billion in 2011.
If approved, Relday will be the first subcutaneous antipsychotic product that allows for once-monthly dosing. Zogenix believes that Relday will offer an improved pharmacokinetic profile, significant reduction in injection volume and a simplified dosing regimen due to Durect Corporation's (DRRX) Saber controlled-release depot technology.
Life After Zohydro
After the negative Zohydro vote, Zogenix shares plummeted to an all-time low of $1.11 from $2.36 before the vote. The company's shares appear to be slowly recovering. On January 3, Zogenix shares reached $1.46.
Zogenix's first commercial product, Sumavel DosePro (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Sumavel DosePro is the first and only needle-free delivery system for subcutaneous sumatriptan for the treatment of acute migraine and cluster headache.
Mallinckrodt LLC, the pharmaceuticals business of Covidien (COV), and Zogenix co-promote Sumavel DosePro. Mallinckrodt's 95 salesperson strong U.S. sales force sells Sumavel DosePro to its customer base of prescribers. Zogenix records all product revenues and Mallinckrodt will be compensated based on a percentage of net sales from prescriptions generated by Mallinckrodt. The agreement runs through June 30, 2014, and may be extended.
For the third quarter of 2012, Sumavel DosePro generated $8.5 million net product revenue, a 5% increase over the second quarter 2012, and maintained consistent refill rate at 43% from the second quarter 2012.
The company's validated, proprietary DosePro needle-free technology platform has a broad range of applications, and can be a solution for self administration of subcutaneous pharmaceuticals and biologics.
I think it is a wise move for Zogenix to diversify and not put too much emphasis on the pain business. These are precarious times for pharmaceutical companies developing pain killers, especially opioid drugs, as the FDA continues to seek a balance between minimizing opioid drug abuse and enabling the appropriate treatment of pain.
The FDA is holding a two-day public hearing to obtain information, such as scientific evidence and study data, on issues related to opioid use. At the hearing, to take place February 7-8, 2013, the FDA seeks to obtain information from expert members of the public on the following topics:
- Diagnosis and Understanding of Patient Pain.
- Understanding and Adhering to the Labels of Pain-Treating Products.
- Limiting Opioid Prescription and Use.
Information about the conference can be found here.
The FDA approved 39 new drugs in 2012 which represents the most since 1996. Hopefully, Zohydro will find better fortunes in 2013. It may be a pivotal year for the company.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.