The California-based company worked with drug development firm Altus Formulation to produce a tablet version of the hydrocodone product designed to prevent patient misuse and addiction.
Zogenix agreed last November to pay $750,000 (€550,000) to access Altus’s Intellitab drug delivery platform, with potential development and regulatory milestone payments of $3.5m up to NDA submission.
Damon Smith, Altus CEO, told in-Pharmatechnologist.com the companies had modified Zohydro in several ways to prevent the medicine being crushed for chewing, snorting or injection, common ways to bypass extended-release formulations and obtain a quicker “high.”
The tablets were made extremely hard, to prevent their being broken and chewed. They are also resistant to alcohol, sometimes used as a solvent.
Secondly, said Smith, the new versions contain “super absorbent materials to absorb household liquids and alcohol to stop injection. As all tablets can be broken, we want to ensure that if ours are, if liquid is added, they form a plug that hinders draw up into a syringe and prevents ejection from a syringe.”
He added that the pills have been designed to retain their controlled-release properties even if crushed into pieces, and that they absorb liquid from nasal secretions to stop drug release in the nose.
Tablet and capsule
Zogenix said it will file a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) by October 2014 for a next-generation formulation of Zohydro ER Extended Release capsules. If approved, the new formulation could be on the market by early 2015.
The company will seek to have the product labelled as having abuse-deterrent properties under the FDA’s current draft Guidance for Industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
Zogenix said it will follow the capsule filing with a new drug application (NDA) submission for a tablet formulation in early 2016. The application will refer to the safety and efficacy findings of the approved, current capsule version of Zohydro ER, “greatly simplifying its development programme,” said the company.
Zohydro was approved by the FDA in October 2013, and reached the market earlier this year despite a petition by addiction campaigners who claimed the drug is five to ten times stronger than Vicodin and could cause a first-time overdose.
Zogenix responded, saying the drug is intended to be taken less often in a 24-hour period than other hydrocodone products, and that it is intended only for patients in chronic pain who have exhausted other therapies.