In the early stages of treatment for Parkinson’s Disease Levodopa is a popular option for patients. As the effects of the medication wear off it can make life difficult for these patients as they wait for their next dose. A new inhaled formulation could help fill in the gaps for this patient population.
A new formulation of dopa and instead of see here is it’s administered by inhalation its uptake through the lungs is to achieve rapid and reliable onset of effect to rescue people from being in off states and people we have advanced parkinson’s disease or even just a few years of it very often experience wearing off of medication affect the drug works very well
For them but sometimes as soon as two or two-and-a-half hours after taking the oral dose it can wear off sometimes quite abruptly and leave them in the lurch with parkinsonian symptoms immobility tremors stiffness pain even and how to rescue themself from this situation is a challenge in some instances the oral medicine won’t kick in for perhaps an hour or more
It just sits there in the stomach and other instances it’s at least a 30-minute wait and who can wait that long so the purpose the target of this this drug is that window between when the oral medicine typically will work and let’s say the maximal a speed of action in our study we found a clinically meaningful effect from inhaling this micro particulate form of
Levodopa within 10 minutes the maximal effect took longer to occur but a clinically meaningful effect was there at 10 and 20 minutes later and it seemed to occur quite reliably with the product as it’s currently developed the study is a phase 2b trial it isn’t the definitive answer and for developing a drug and getting approval it may take longer and larger scale
Studies to confirm the results that we have so far levodopa product 35 or 50 milligrams that was used of course this is totally unlike what the gi tract is taking up that’s 100 milligrams typically or 150 or 200 milligrams per dose but the uptake seems to be highly efficient and as a powder it gets right into the lung space and is in the bloodstream and perhaps
Bypasses some of the first pass metabolism and other deviations that levodopa has on his way to the brain the concept here of rescue or filling in the gaps so that a patient who would hail this presumably would take an oral dose and in the same time that this drug is kicking in and perhaps wearing off the next oral dose might be going to work just to give that
Patient two three four hours of effect so this is a as needed kind of therapy it isn’t replacing conventional oral medication but it sounds like you know if this product were out there patients could count on this to go out in the world and not not be afraid of getting stuck in traffic or unsafe situations like that typically in the first two years after starting
Levodopa patients don’t have this kind of fluctuation this is a phenomenon that starts to begin for some people after the second third year and by the time three to five years has elapsed up to fifty percent of people on levodopa will notice that the drug wears off to some extent between doses a severe off state off meaning not being mobile and so on is actually a
Very small number of people but it does occur and certainly even wearing off and tremor coming up in social situations is undesirable so it’s a very frequent problem as the disease goes on and yet these patients are levodopa responsive they just can’t store up the effect of the drug for longer than perhaps the two to three hours of time that the drug is in their
Bloodstream the drug seems to no substance the novelty of delivering it to the lungs of course brought up a very careful program of scrutiny for safety including breathing tests and other measures of lung function fortunately there had already been products that have fused this route using powder inhalation including the technology that’s used here was used for
Insulin delivery so we are in the study carefully looking at safety data and fortunately the results were reporting don’t show any signal for problems other than some report of coughing and sputum the stuff that one coughs up being discolored but there doesn’t seem to be any major concerns from the signal here that this wouldn’t be useful for some patients the
Product is under further development the company developing at 1/4 therapeutics is interested to see this on the market i assume and i don’t think based on the data so far that there should be necessary any modifications for the future plan of how the product is formulated as a device or the doses picked it looks like it’s on track for further development and
Filling an unmet need of rescue therapy for the patients who otherwise has this uncertainty in their life
Transcribed from video
New Formulation of Levodopa Aims to Serve as Rescue Treatment for Parkinson's Patients By HCPLive
