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news.KemPharm has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application titled, "Benzoic Acid, Benzoic Acid Derivatives and Heteroaryl Carboxylic Acid Conjugates of Hydromorphone, Prodrugs, Methods of Making and Use Thereof."
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The patent application governs composition of matter for KP511, KemPharm’s prodrug of hydromorphone.
KP511 is the second most advanced product candidate in KemPharm’s pain therapy portfolio, which includes KP201, the company’s lead product candidate, which is a prodrug of hydrocodone, and KP606, a prodrug of oxycodone.
Similar to KP201, which was granted composition of matter protection (USPTO Patent No. 8,461,137), KP511 is a new chemical entity designed to offer unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC).
In preclinical studies, KP511 exhibited superior pharmacological characteristics that may suggest an improved safety profile compared to currently marketed hydromorphone products, possibly reducing or preventing symptoms of constipation and limiting abuse potential.
KP511 also features tamper resistant properties that make it difficult to extract hydromorphone from the prodrug, which is not active until cleaved in the body. Additionally, at high doses, KP511 has shown the potential to saturate the processes that metabolize it to hydromorphone thus hypothetically limiting or eliminating the risk of overdose.
KemPharm president and CEO of Dr Travis C Mickle noted the company’s strategy is to leverage its Ligand Activated Therapy (LAT) prodrug technology to develop a franchise of new chemical entities designed specifically to address key shortcomings with currently marketed opioid-based therapeutics, namely abuse potential and constipation, in order to provide patients and care providers with better, more responsible options for treating pain.
"Today’s patent allowance for KP511 serves to further cement the differentiation of our technology platform as well as strengthen the value potential of the drug and our overall pipeline," Dr Mickle added.