UPDATED
A small, implantable device being designed to deliver extended-release pain medicine aims to ensure patient compliance and stymie opiate abuse.
Axxia Pharmaceuticals is developing an implant the size and shape of a shirt button that can subcutaneously deliver an opiate for 30 to 90 days without any moving parts. The first application of the technology will deliver hydromorphone for treatment of moderate to severe chronic pain in cancer patients. CEO Wayne Pollock said the company plans to file an Investigational New Drug application for the implant by the fourth quarter of 2012.
According to the company’s website, it can deliver continuous dosing without an initial burst of the drug upon implantation and without slowing down as the concentration of the drug decreases. The minimally invasive device can also be easily manufactured with different dosages and release durations, and can be implanted and removed by a nurse or physician’s assistant in less than 10 minutes without sutures, the company says.
It’s nonbiodegradable and made from nonallergenic materials that are already approved for use in humans. Hydromorphone, the active ingredient, is a generic but potent pain medication that’s already approved and commonly used to treat patients with cancer-related pain.
In many countries, patients don’t have adequate access to pain medication because of regulations that attempt to control abuse, and Axxia’s website suggests that the company is looking at international markets for its device. BCC valued the global market for pain management drugs and devices at $19 billion in 2008 and estimated it would grow 11.5 percent annually through 2013.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Other novel methods for extended-release delivery of opioids include transdermal patches and an intranasal device being developed by NeuroPharma. Concerns with implanted delivery devices currently on the market include surgery safety, dosing errors, infection and pump inversion. Many of these devices also aren’t designed to deliver opioids, Axxia says.
As disclosed in a recent U.S. Securities and Exchange Commission filing, the Bel Air, Maryland company is currently in the process of raising $800,000.
[Photo from graur razvan ionut]
