New Gains for Pain - Pharmaceutical Executive

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New Gains for Pain
The palliative-care market is set to explode. Here's an overview of what to expect.


Pharmaceutical Executive


With its recent acquisition of Cima Labs (2004), Cephalon added OraVescent fentanyl, a sublingual (under the tongue) tablet, to its pipeline. As a follow-up product to Actiq, OraVescent boasts potentially faster drug absorption rates than its predecessor. The drug is currently in Phase III, and Cephalon expects it to launch in 2006.

Fine-tuning drug delivery methods seems to be even trickier for chronic pain indications than it is for shorter-term relief agents. To prevent the overdosage and underdosage frequently associated with pills and patches, Durect has been developing Chronogesic (sufentanil), a subcutaneous implant system that aims to provide three months of pain relief by releasing sufentanil (an opioid) in controlled doses. Although currently in Phase III, Chronogesic trials were halted in July because of problems with premature shutdown of drug delivery, and it will require product design re-engineering before development resumes.

Emerging Phase III drug candidates adopt a variety of delivery platforms, but current Phase I and II drugs involve various combinations, including inhaled, intranasal, subcutaneous, and transmucosal formulations of morphine, fentanyl, and ketamine, a nonbarbiturate anesthetic.

Abuse resistant technology. Following the October 2003 public announcement of Rush Limbaugh's addiction to Purdue Pharma's potent opioid OxyContin (extended-release oxycodone), the issue of misuse and abuse of pain medicine resurfaced. Consequently, companies developing abuse-resistant technologies are expected to contribute to the growth of the pain-management segment.

Pain Therapeutics, for example, is developing Remoxy, a long-acting oxycodone with abuse-deterrent properties. The company, which is benefiting from an accelerated development timeline granted by FDA, completed Phase I trials in mid-2004 and expects to initiate Phase III trials by the end of this year.

Remoxy is expected to be a direct competitor of OxyContin. Its success will depend on its pricing structure and negotiated reimbursement levels—how much more expensive it will be than OxyContin, especially because generic ER oxycodone will enter the market in 2005. In addition, Remoxy may be of little utility in certain patient populations, such as terminal cancer patients undergoing end-of-life care, when addiction or abuse are not issues.

As the pain-management market grows, delivery technologies that facilitate ease of use, immediate relief, and long-lasting treatment will add significant value to both current and emerging pain treatments as well as command higher pricing premiums.

More Education Needed Despite increasing therapeutic choices for pain management, many patients remain undertreated. According to the American Pain Society (APS), only 40 percent of patients with chronic pain are appropriately treated. This statistic is explained, in part, by the lack of physician education in proper pain management. "Most physicians are trained to treat the underlying disease and not the pain that is associated with the disease," according to AlgoRx's Burch.

For example, in a survey in May of 100 physicians, most reported that their pain management education was less than satisfactory. More than 70 percent of the physicians felt that their pain management education during medical school and residency was poor. and they said they only became familiar with pain-management measures after they began practicing. Surveyed pain specialists reported that they believe even the most seasoned oncologists undertreat pain in cancer patients.

In addition, the cancer pain survey revealed that 30 percent of physicians do not follow existing treatment guidelines simply because of a lack of exposure to the latest recommended protocols. Rather, many doctors choose to prescribe products that are available at their medical facility and often revert to treating patients subjectively. Such procedural inconsistencies are unfortunate for patients because—as highlighted in a November 2003 Duke University Medical Center study—pain management in accordance with proper treatment guidelines increases the rate of pain medicine's effectiveness compared with unguided treatment.

Such systematic undertreatment negatively affects the quality of life for pain sufferers and hinders growth of the pain- management therapeutics market. "Education in pain management is the most important factor to consider in marketing efforts for a new drug," says Burch. "We must show physicians how to use the drugs that are available to them."


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