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news.Cynapsus, a specialty clinical development pharmaceutical company targeting diseases of the brain, has reported positive results of the proof-of-concept studies comparing prototypes of its lead drug candidate APL-130277, a potential treatment for patients with Parkinson's disease, to injectable apomorphine.
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APL 130277 is a reformulation of the currently marketed injection into an oral formulation that will follow an expedited clinical development path of 18-24 months based on the FDA’s 505b(2) submission process.
In addition to addressing the needs of severe Parkinson’s patients who currently have access to only the inconvenient and painful subcutaneous apomorphine injection, APL 130277 has the potential to become adjunctive therapy for moderate Parkinson’s patients as well, Cynapsus said.
Cynapsus has demonstrated that its thin-strip prototypes dissolve rapidly under the tongue in a reasonable period of time achieving the targeted Tmax.
As per the study Cynapsus’ thin-strip prototypes deliver appropriate quantities of drug to the blood stream achieving targeted AUC and Cmax.
Cynapsus has achieved blood levels and a pharmacokinetic (PK) profile that are very similar to the FDA-approved injectable delivery of apomorphine hydrochloride
A survey of 11 large US payers (HMO and insurers) gauged the opinion and acceptance onto formulary of APL 130277, Cynapsus Therapeutics’ oral thin film formulation of apomorphine for the treatment of Parkinson’s disease.
The results indicate that APL 130277 may be readily accepted on formulary by payers and reimbursed at price levels at or near the level at which apomorphine injection is currently reimbursed.
The survey results showed that Over 90% of respondents would reimburse APL 130277 within 3 months of approval of the drug by the FDA.
Cynapsus president and CEO Anthony Giovinazzo said the company will work towards a pre-IND Meeting with the USFDA in H1 2011, and expect to file an IND and complete the first in man study by the end of 2011.
"As this is a new delivery method of an approved drug, we continue to pursue a shortened regulatory path that could see a new drug application being submitted in H2 2013 or early H1 2014," Giovinazzo said.