NEWARK, Calif., Sept. 08, 2016 (GLOBE NEWSWIRE) -- Depomed, Inc. (NASDAQ:DEPO) announced today the presentation of clinical data from 10 trials and studies involving NUCYNTA® ER, Gralise® Lazanda® and a novel, first-in-class investigational agent, cebranopadol at PAINWeek® 2016 being held in Las Vegas.
“Depomed is pleased to continue its strong presence at the nation's largest annual meeting for frontline pain management clinicians with presentations highlighting the truly differentiated properties of our product portfolio,” said Srinivas Rao, M.D., Chief Medical Officer of Depomed.
The posters will be available for viewing this morning with author-led presentations this evening from 6:30pm – 8:30pm at the Scientific Session and Reception.
Two posters describe studies of NUCYNTA ER conducted by the Rocky Mountain Poison & Drug Center analyzing data compiled from the Researched Abuse, Diversion and Addiction-Related Surveillance System (RADARS®) Poison Center Program
• One describes an analysis of real-world data regarding the risk of unintentional exposures in children less than six years old to NUCYNTA ER, other extended release (ER) opioids and/or IR opioids and found that the risk of serious adverse events per gram of opioid dispensed for other ER opioids was 4 times higher than for NUCYNTA ER.
• The second reports 36 instances of intentional abuse and misuse exposures in the U.S. involving NUCYNTA ER and 526 instances for non-abuse deterrent formulation (ADF) ER opioid tablets/capsules and found that non-ADF ER opioid tablet/capsule cases were more than two and a half times more likely to involve tampering than NUCYNTA ER. None of the NUCYNTA ER cases resulted in a major medical outcome or death among intentional abuse and misuse cases, compared with 13% for non-ADF ER opioids.
- The poster “Comparison of Pharmacokinetics and Simulated Driving Performance Healthy Volunteers Taking Therapeutic Doses of Gastroretentive Gabapentin, Gabapentin, or Pregabalin” describes a double-blind, placebo-controlled, crossover study of 28 healthy volunteers to determine the relative impact of Gralise, gabapentin, and pregabalin on both daytime function—assessed by driving simulator performance— showed that greater impairment was observed for the primary driving endpoint for gabapentin and pregabalin than for Gralise, reaching statistical significance. Neurological symptoms, such as tremor and visual disturbances were seen at a lower frequency for Gralise than gabapentin, with less frequent adverse events for Gralise versus gabapentin, and pregabalin, a difference which may reflect Gralise’s distinct pharmacokinetic profile.
- The poster “Updated and Validated Comparison of Plasma and Cerebrospinal Fluid Fentanyl Pharmacokinetics and Bioavailability When Delivered Intranasally or Sublingually” presents data from a partially randomized, open-label, three-way crossover, single-center study comparing two transmucosal formulations of fentanyl (Lazanda nasal spray and Subsys® sublingual spray) in 13 healthy subjects shows that systemic fentanyl exposure was numerically higher when administered intranasally versus sublingually, while the exposure to fentanyl’s primary metabolite, norfentanyl was lower.
- The poster “Cebranopadol, a Novel First-in-Class Analgesic: Optimization of the Up-titration Regimen to Individual Best Dose for Patients Suffering from Moderate to Severe Chronic Pain” reviews data from four Phase II/III clinical trials conducted by Grünenthal GmbH (“Grünenthal”) of cebranopadol on the possible impact of various titration schemes on tolerability. These data will inform a new titration scheme for Phase III clinical development in chronic non-malignant pain. Additionally, poster “Cebranopadol, a Novel First-in-Class Analgesic: Results from a Study in Patients with Moderate to Severe Pain Following Bunionectomy” reviews data from a randomized, multi-center, double-blind, placebo- and active-controlled trial to evaluate the analgesic efficacy and safety of a single dose of cebranopadol in 258 patients with moderate to severe post-operative pain following bunionectomy. Data show that cebranopadol provided dose-dependent analgesic efficacy with good tolerability in these patients.
- Data from the Grünenthal-conducted cebranopadol trials in mixed chronic low back pain (cLBP) and diabetic peripheral neuropathy (DPN) as well as from the human abuse potential and respiratory studies were previously presented at 8th World Congress of the World Institute of Pain (WIP) in May 2016, with results discussed in a press release dated May 23, 2016.
Electronic copies of these posters are available upon request.
Depomed company representatives will be hosting conference attendees at its booth, #217.
Depomed is a leading specialty pharmaceutical company focused on enhancing the lives of the patients, families, physicians, providers and payors we serve through commercializing innovative products for pain and neurology related disorders. Depomed markets six medicines with areas of focus that include mild to severe acute pain, moderate to severe chronic pain, neuropathic pain, migraine and breakthrough cancer pain. Depomed is headquartered in Newark, California. To learn more about Depomed, visit www.depomed.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to the commercialization of NUCYNTA ER, NUCYNTA, Gralise, CAMBIA, Zipsor and Lazanda, those related to development of cebranopadol and other risks detailed in the company's Securities and Exchange Commission filings, including the company's most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q. The inclusion of forward-looking statements should not be regarded as a representation that any of the company's plans or objectives will be achieved. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Investor Contact: Christopher Keenan VP, Investor Relations and Corporate Communications 510-744-8000 firstname.lastname@example.org