June 18, 2013
We held a conference call with an MCRI consultant who participated in one of
the Nuedexta trials conducted in diabetic neuropathic pain. He believes Nuedexta
is a very safe and effective drug for neuropathic pain caused by multiple
conditions, and drugs with new mechanisms of action are needed. To obtain an
expanded label AVNR will probably need to conduct two new pivotal trials vs. an
active comparator. The recent news that ADP-786 can be moved forward with a
505b2 regulatory path is important since it will require less quinidine. Nuedexta
has demonstrated statistically significant reductions in pain scores in several
pivotal trials at doses higher than the approved dose of 20 mg dextromethorphan
(DM) and 10 mg quinidine (Q). T2D patients received BID daily doses of 45 mg
DM/30 mg Q, 30 mg DM/30 mg Q, or placebo. Both doses had statistically
significantly lower pain ratings than placebo patients (p
Sentiment: Strong Buy
But with MS neuropathic pain Avanir can do studies versus placebo, an active comparator is not necessary.
That's partly why Avanir chose MS neuropathic pain to proceed with.
So SummerStreet and/or their consultant didn't listen to Avanir on the subject.
But I agree it is likeley Avanir will have to do at least two Phase 3 studies for MS neuropathic pain.
DPN studies would definitely be more complex. In fact, probably not as simple as active comparator studies. D/Q does not necessarily have to be "non-inferior" to current medications in order to be useful. It has a different mechanism of action so it needs to be useful as an add-on therapy or useful in a sub-population where currently approved medications fail. Of course a non-inferiority study would be helpful in order to compete head to head with other pain medications but price differences would likely limit D/Q unless a truly superior performance could be shown (in a sub-population would be enough). However, DPN is a pretty tough group to show actual superiority vs. active compounds given the high placebo effects.
Sorting through all of the above as to what study is most cost-effective would be tough. Maybe they can get it on the market for pain and clinical experience will be an invaluable guide.