Approval is a certainty. My own view, though, is that the market for Droxidopa will be small for a few reasons. Patients who suffer from NOH appear to build up a tolerance to effective drugs. Midodrine, for instance, is extremely effective, especially if taken in sufficient dosage early morning to mid afternoon to avoid night-time supine hypertension; however, tolerance is quite common. Midodrine will be approved again maybe in 2014. I am sure the studies by Shire will show only short term effectiveness. CHTP's Droxidopa studies have also shown only short term effectiveness, but its supine hypertension profile is very good. On the other hand, it only raises SBP about 5.6 mm Hg. But Midodrine is shown to reduce SDP 10-20 mm Hg. In my opinion, Midodrine will be the first drug prescribed for most patients, with many patients switching between meds until they find the right mix.
At this price CHTP still looks like a good buy. Most likely though I will sell on approval.
Your opinion is welcomed here. You sound like you might be involved in health care delivery. Your analysis did not touch on the differences in side effects between Droxidopa and Midodrine. Most of the patients that would be candidates for either of these medications also suffer from a variety of other disorders such as severe organic heart disease, acute renal disease and other problems related to age for which Midodrine is containdicated. While Droxidopa has been in use in Japan more than 20 years and has proven to have very few side effects of which most are mild. Patients have reported tachycardia, hypertension, nausea and vomiting, and headache or migraine. I would think a well informed Physician would opt for the less toxic treatment. I believe that Shire will not even seek final approval if Droxidopa is approved. Of course that is just my opinion.
used the way it should be used? What, with terrible misinformation? Shire seeking approval for midodrine? What planet are you people on? Midodrine is approved, has been for many years. The old CHTP CEO advertising to the world how the FDA screwed up by approving midodrine is the reason droxidopa is not yet approved. FDA does not like being called out and retaliation was the briefing document followed by the CRL. Now that we fired the people responsible for throwing the FDA under the bus, and suffered the consequences of FDA retaliation, everything should be good. FDA showed CHTP who is boss and now should end the NOH patient suffering with a complete 180 approval with flying colors.