Updated: QRx Pharma a high-stakes gamble in the FDA’s upcoming decision Print E-mail
By Brian Wilson, Contributor   
Wednesday, 20 June 2012 04:09

Sydney, Australia based QRx Pharma (QRXPY) (ASX: QRX) is a pharmaceutical company with the vast majority of its prospects tied up in a single drug – MoxDuo. MoxDuo is a combination of two widely used opioids (3:2 ratio of morphine and oxycodone). In the combination of these two into a single analgesic, QRx claims that synergetic effects are possible which can ultimately reduce dosage and side-effects for patients undergoing pain therapy.

Since the market for pain medications is enormous, at about $2.5 billion, QRx hopes to demonstrate that their patented MoxDuo formula can outperform the originals and carve out a sizable piece of that market share. To better cater to the drug market, their protected formula is being developed in three forms – immediate release, controlled release, and intravenous. In addition, the Swiss pharmaceutical company Actavis has signed a License and Option Agreement (LOA) to help commercialize MoxDuo IR.

MoxDuo immediate release capsules will be the first commercially available product if all goes well. After almost four years of phase III trials and an NDA submission on August 25th 2011, the drug sits somewhere in a large stack of FDA paperwork as an NDA with a PDUFA action date of June 25th.

Although there are technically three compounds undergoing clinical trials, the real test for QRx is in the approaching FDA decision. An approval of MoxDuo IR will pave a much easier path for the intravenous and controlled-release versions of the drug, since the active ingredients identical. The decision rests heavily on the recently completed phase III dose-response study in acute pain. The study, which involved 256 patients, tested four dosages of MoxDuo using the numeric pain rating scale (NPRS), with the primary endpoint being the summation of pain intensity differences over 48 hours relative to the baseline.

The results were statistically significant and clear from the data, but NDA decisions aren’t clearly predicted, since MoxDuo will also have to prove to be a considerable upgrade over morphine and oxycodone. Addressing this particular concern, MoxDuo IR was studied in a combination rule phase III trial with 522 patients which compared the compound to separated treatments of morphine and oxycodone with regards to efficacy (measured by the NPRS) successfully.

Since QRx is highly dependent on MoxDuo, I expect that the FDA decision regarding MoxDuo IR will have tremendous impact on the price of shares. A clean approval could cause shares to continue another leg in their multi-year rally, perhaps going as high as $3/share. On the other hand, a rejection could bring up fears over the true efficacy of the viability morphine/oxycodone and spark a major selloff which could send shares into a ditch for a quite some time. So, for the most part, QRXPY is simply a high-stakes gamble in the FDA’s decision on June 25th.

Note: This article was updated to include mention of the trial comparing moxduo versus plain oxycodone and morphine.

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