Apadaz (benzhydrocodone/acetaminophen) / Zevra Therap, KVK Tech, Sure Med Compliance - LARVOL DELTA

Opioids for pain. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • Pain

Comparison table: Some oral/transdermal opioid analgesics. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Pain

KemPharm Reports Third Quarter 2020 Financial Results (GlobeNewswire) - "Corporate and Regulatory Highlights:...Announced that its commercial partner for APADAZ®, KVK-Tech, Inc., entered into a collaboration agreement with Sure Med Complianc...'KVK-Tech’s collaboration with Sure Med Compliance has the potential to build greater prescriber awareness for APADAZ while focusing on providing education to physicians, pharmacies, and patients regarding responsible opioid therapy.'"

Licensing / partnership • CNS Disorders • Pain

KemPharm’s Commercial Partner for APADAZ, KVK-Tech, Enters into Collaboration Agreement with Sure Med Compliance Focused on Improving Prescribing Education and Compliance for Pain Therapies (KemPharm Press Release) - "KemPharm, Inc....today announced that its commercial partner for APADAZ®, KVK-Tech, Inc. (KVK), has entered a collaboration agreement with Sure Med Compliance (Sure Med)...The program aligns APADAZ (benzhydrocodone and acetaminophen tablets, CII) with Sure Med’s Care Continuity Program® (CCP) in a new study program to generate anonymized patient outcome and utilization data that will measure the impact of switching patients from other hydrocodone/acetaminophen products to APADAZ, where appropriate."

Licensing / partnership • CNS Disorders • Pain

KemPharm, Inc. expands global intellectual property estate for KP201 (PRNewswire) - "KemPharm...announced today that multiple global composition of matter patents have been issued for KP201 in Russia, Ukraine, Kazakhstan, Japan, Australia, New Zealand and South Africa. Additionally, the United States Patent and Trademark Office (USPTO) allowed for grant in due course...to KemPharm for composition claims of the salt forms of KP201."

Patent • Pain

KemPharm (KMPH), Acura Pharma (ACUR) enter Aversion tech licensing agreement (Streetinsider.com) - "KemPharm...and Acura Pharmaceuticals...announced that they have entered into a License Agreement (the 'Agreement') whereby Acura will provide its proprietary Aversion Technology to KemPharm to use with its current and in-development immediate release (IR) opioid product candidates....The Agreement provided for an upfront cash payment of $3.5 million to Acura at execution and grants KemPharm development and commercialization rights for up to three IR product candidates containing two of KemPharm’s opioid prodrugs."

Licensing / partnership • Demo Pain • Pain

KemPharm, Inc. advances KP201 clinical program with initiation of human abuse liability and human gastrointestinal motility trials (PRNewswire) - "KemPharm...announced today the initiation of clinical trials of KP201 designed to investigate the drug candidate's ability to deter abuse and reduce opioid-induced constipation....The human abuse liability program will consist of three separate studies comparing KP201 with Norco®...The first, a non-clinical study with data expected prior to year-end 2014, will evaluate KP201's tamper resistance...The second and third, both clinical trials, are designed to measure the likability of KP201, as compared to Norco®..."; Anticipated completion of all of the studies by the first half of 2015.

Anticipated trial completion date • Trial initiation date • Pain

KemPharm announces FDA Advisory Committee Meeting for lead abuse-deterrent drug candidate KP201/APAP (GlobeNewswire) - "KemPharm...today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for May 5, 2016, to review KemPharm’s New Drug Application (NDA) for KP201/APAP..."

Anticipated FDA event • Pain

KemPharm (KMPH) announces key corporate and clinical updates (Streetinsider.com) - "KemPharm has recently received and reviewed the minutes from the EoR meeting and has notified the FDA that the Company will elect to continue the regulatory review process with the submission of a Formal Dispute Resolution Request (FDRR). KemPharm anticipates up to twelve months may be required to complete all parts of the FDRR process."

Regulatory • Demo Pain • Pain

KemPharm, Inc. to present at Biotech Showcase 2014 (PRNewswire) - "KemPharm...announced today that president and CEO, Travis Mickle, Ph.D. will present at the Biotech Showcase™ 2014 Conference being held in San Francisco January 13-15, 2014. Among the topics to be discussed, Dr. Mickle will provide an overview of KemPharm's development pipeline, including KP201..."

Conference • Pain

KemPharm, Inc receives USAN approval for nonproprietary name of novel pain drug candidate, KP201 (PRNewswire) - "KemPharm, Inc...announced today that the United States Adopted Name (USAN) Council approved the use of the nonproprietary name, "benzhydrocodone," for its lead pain candidate, KP201...KP201 is in development for the treatment of acute moderate to moderately severe pain with a new drug application (NDA) expected to be filed in Q2 2014."

Anticipated NDA • Regulatory • Pain

KemPharm (KMPH) says clinical trial reaffirms properties of KP201/APAP (Streetinsider.com) - "KemPharm...today announced the completion of its human abuse liability program of KP201...and reported top-line results from the KP201.A02 intranasal human abuse liability clinical trial. This trial was a phase 1 type clinical trial in 42 healthy, non-dependent recreational drug abusers...KemPharm plans to present the full human abuse liability data package as part of its New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to the U.S. Food and Drug Administration (FDA) as early as by the end of 2015."

Anticipated NDA • P1 data • Pain

KemPharm to present data from oral human abuse liability study for investigational drug KP201/APAP at the 2016 AAPM Annual Meeting (GlobeNewswire) - "KemPharm...announced that it will present data from an oral human abuse liability, pharmacokinetic and safety study (KP201.A01) of KP201/APAP, today at the 32nd Annual Meeting of the American Academy of Pain Medicine (AAPM) in Palm Springs, CA....The poster titled, 'Oral Abuse Potential of Benzhydrocodone, a Novel Prodrug of Hydrocodone,' will provide a review of the full data package from the KP201.A01 trial."

Anticipated PK/PD data • Pain

KemPharm, Inc. secures $60 million commitment from Deerfield (PRNewswire) - "Multi-Tranche Financing Provides Sufficient Funding to Take KP201 Through and Beyond Potential FDA Approval and Enables KemPharm to Advance its Full Pipeline of Abuse-Deterrent Prodrugs."

Financing • Pain

"@US_FDA approved Apadaz today, an intranasal #opioid. Very concerning is @KemPharmInc's expectation of a "very high-volume market". In the middle of an #opioidcrisis, we don't need this. #RememberStadol https://t.co/I03qkBjbuu" (@SeanKarbs)

Biosimilar

Benzhydrocodone/acetaminophen (Apadaz) for pain. (PubMed, Med Lett Drugs Ther) - No abstract available.

Journal

KemPharm reports Apadaz will be available nationally beginning in November 2019 (GlobeNewswire) - "KemPharm...today provided a commercial update related to its FDA-approved prodrug product, APADAZ...which has been licensed to KVK-Tech, Inc. ('KVK-Tech') for commercialization. Specifically, KVK-Tech has informed KemPharm that APADAZ and its authorized generic (AG-APADAZ) will be available nationally beginning in November 2019....KemPharm provided updates on formulary access for AG-APADAZ, including its inclusion on the preferred drug lists for the respective Medicaid plans in Alabama and Utah."

Commercial • Reimbursement

KemPharm provides update on Apadaz formulary adoption (KemPharm Press Release) - "KemPharm...today provided an update on formulary adoption of its FDA-approved prodrug product, APADAZ...According to Managed Markets Insights and Technology...estimates, the authorized generic of APADAZ...currently has unrestricted formulary access for 91% of Commercial lives and unrestricted access for 90% of state Medicaid lives. In addition, MMIT estimates indicate that branded APADAZ currently has unrestricted formulary access for 15% of Commercial lives, generally at a Tier 3 or equivalent reimbursement status."

Commercial

KemPharm announces FDA approval of sNDA for two additional strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP) (GlobeNewswire) - "KemPharm...announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for two additional strengths of APADAZ®, an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP)."

sNDA