Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Lasers, you are making unwarranted assumptions.

All indications are that the Naltrexone in ALO-02 is leaking thereby causing Nausea and Vomiting.

1. The abstract does not say all users are chronic opioid users, only that that there was an open label conversion/titration study. This could also include opioid-naive patients that are being started on long-acting opioids for the first time. This could result in nausea and vomiting.

2. The conversion of one opioid to another could result in nausea and vomiting.

3. Up-titration to higher dose of oxycodone could result in nausea and vomiting.

4. Change from short-acting to long-acting opioids could result in nausea and vomiting.

5. Adverse event rate is the same among treatment and placebo group. Although the percentage of types of events within each group is not listed, this does not support an implication that naltrexone leakage contributed to adverse events.

6. 57% positive response rate is not indicative of naltrexone leakage, and is comparable to published Zohydro hydrocodone data (68% vs 31%).
http://www.ncbi.nlm.nih.gov/pubmed/24517082