Vantrela ER (hydrocodone bitartrate) / Teva - LARVOL DELTA

Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time (clinicaltrials.gov) - P3, N=220;

Pain

Study to evaluate the efficacy and safety of hydrocodone bitartrate extended-release tablets (CEP-33237) for relief of moderate to severe pain in patients with osteoarthritis or low back pain who require opioid treatment for an extended period of time (clinicaltrials.gov) - P3, N=391; Recruiting -> Completed; N=470 -> 391

Trial completion • Pain

Relative Intranasal Abuse Potential of Hydrocodone ER (AAPMgmt 2016) - "Intact oral hydrocodone ER liking scores were similar to those of placebo. Drug liking measures reflected the observed pharmacokinetics."

Clinical • Biosimilar • Demo Pain • Pain

Teva gains recommendation for approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) extended-release tablets CII formulated with proprietary abuse deterrence technology (Teva Press Release) - "Teva Pharmaceutical...today announced that 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) voted 14 to 3 to recommend approval of VANTRELA™ ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate....Committees voted that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the oral, nasal, and intravenous routes of abuse."

FDA event • Demo Pain • Pain

Study to evaluate the long-term safety of hydrocodone bitartrate extended-release tablets (CEP-33237) in patients who require opioid treatment for an extended period of time (clinicaltrials.gov) - P3, N=330; Enrolling by invitation; N=220 -> 330

Enrollment • Pain

Correlation of Pharmacokinetic (PK) and Subjective Pharmacodynamic (PD) Parameters: An Exploratory Post Hoc PK-PD Analysis from Two Human Abuse Potential Studies With a Hydrocodone Extended-Release Tablet Formulated With CIMA® Abuse-Deterrence… (PAINWeek 2016) - "These correlations were stronger than reported previously, potentially because of very slow kinetics and lack of abuse-related effects with intact oral hydrocodone ER. These exploratory data from abuse potential studies of hydrocodone ER formulated with CIMA® ADT platform demonstrate that, under some conditions, PK and subjective PD effects are correlated."

PK/PD data • Biosimilar • Demo Pain • Pain

A crossover study to assess the bioequivalence of hydrocodone bitartrate extended-release tablet (clinicaltrials.gov) - P1, N=54; Sponsor: Teva Pharmaceutical Industries; Not yet recruiting -> Recruiting.

Enrollment open • Pain

Evaluation of the Relative Intranasal Abuse Potential of a Hydrocodone Extended-Release Tablet Formulated with Abuse-Deterrence Technology in Nondependent, Recreational Opioid Users. (PubMed, Pain Med) - "Incidences of adverse events for intranasal treatments were 52% for hydrocodone ER, 53% for hydrocodone powder, and 61% for HYD-OF. The statistically significant differences between hydrocodone ER vs hydrocodone powder and HYD-OF for the primary drug liking end points indicate a lower intranasal abuse potential with hydrocodone ER in healthy, nondependent, recreational opioid users."

Journal