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in clinical trials that it can deliver a consistent amount of the drug into the bloodstream, and that nothing really unexpected happens. Batchelder contends that because L-dopa has been well-studied for many years, it won’t have to go through a lot of extra hoops in clinical trials like novel molecules that are just being tested in people for the first time. The first results from what he calls a “proof of concept” trial will be available before the end of 2012, Batchelder says.
If Civitas can prove that its drug is essentially equal to the existing L-dopa, and that it can be delivered in the kind of blood concentrations that are known to control symptoms, then it will be interesting to see how the product might be positioned in the market. The drug is designed to be made into a powder, delivered via a plastic inhaler, which is “about the size of a Bic lighter,” Batchelder says. That means patients could carry it around with them, and give themselves a dose when they feel like symptoms are about to strike, much like how migraine patients feel an “aura” coming on right before a headache hits.
The inhalable drug, at least in the beginning, isn’t being developed simply as a more-convenient replacement for the oral L-dopa. That would be a tough sell, given that the old drug is cheap and generic, and the new drug would probably have a hard time showing it provides superior symptom relief. Animal studies thus far have suggested that the Civitas drug lasts a similar amount of time in the bloodstream as the oral pill, but that the new formulation gets absorbed into the blood more quickly.
If the Civitas drug can navigate trials and eventually reach the market, it could end up providing a bit of a security blanket for many Parkinson’s patients, Batchelder says. Some patients are afraid of what will happen to them at work, or out in social situations, if their drug suddenly wears off and they can’t control their symptoms. The anxiety that comes from that uncertainty actually makes people more likely to suffer symptoms when they are “off” the drug, Batchelder says. So having the inhalable backup in their purse or briefcase could provide valuable peace of mind, as well as a fast-acting drug when it’s needed, he says.
“We believe we could have a big impact on patients’ lives,” Batchelder says.
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