FDA Response To Progenics' Supplemental NDA Application Looms

Progenics (PGNX) is a New York-based pharmaceutical company that is developing a drug called RELISTOR (methylnaltrexone bromide) for the specific treatment of opioid-induced constipation (OIC), which can be a debilitating problem for patients undergoing pain medication.

It is a very common condition. According to a publication in 2010 by the European Society for Medical Oncology, not only can constipation lead to a 30% efficacy decrease of the pain therapy but about 71% of 1210 oncologic patients recruited to the study suffered constipation despite prescribed laxative treatments for the vast majority. Clearly, laxative therapy is deeply flawed.

According to the company's website mu-opioid receptors within the brain and spinal cord, which are targeted by opioids to relieve pain, also exist outside the central nervous system (specifically the GI tract in the case of OIC). This creates serious problems with its function which RELISTOR looks to relieve. More specifically, the drug displaces opioids from the mu-opioid receptors on cells outside of the CNS only. If opioids were displaced on CNS cells, the analgesic effects of any opioid would be eliminated. According to Progenics, RELISTOR does not actually do this due to selectivity.

Although laxative therapy can help, there is still significant unmet demand for an OIC treatment. Occasionally, patients may even require irrigation or manual removal of waste due to a poor response to laxative treatment. RELISTOR is a much simpler option given that it can effectively alleviate OIC symptoms through its interaction with the mu-opioid receptors in non-CNS cells.

In the most recent Phase III clinical trial involving the drug, 1034 patients were tested in a one year safety study of RELISTOR (methylnaltrexone bromide) in non-malignant pain patients with OIC symptoms. In addition to strong toleration for the drug, it was shown that 34.1% of methylnaltrexone 12mg subcutaneous injections resulted in bowel movements within four hours. Subjective assessments were taken too, which showed statistically significant improvements from the baseline with regards to straining and the number of bowel movements along with relief.

RELISTOR has particularly great potential in the oncology drug market. Approximately 90% of patients with advanced forms of cancer experience pain and undergo treatment for it which often leads to OIC symptoms. It has already received marketing approval by the FDA, and is currently waiting for an FDA answer to their supplemental NDA application which would allow for the OIC-preventative treatment in non-cancer patients. The BioMedReports FDA Catalyst Calendar points to an action date of April 27th, 2012.

Back in December, we advised readers that while many of the firm's loyal investors didn't seem to care for "the swing traders who were coming and out" that it was worth watchlisting Progenics and trying to catch the next wave up. That wave came not long after that article. Now, as we await the decision, we're aware that the news may not have an enormous impact on the stock (due to the very likely approval of the drug) but it may still be worth buying more shares upon any unwarranted downturns in the stock.

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Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.