fentanyl transdermal patch / Generic mfg. - LARVOL DELTA

An Open-Label Study of the Pharmacokinetics and Tolerability of Once-a-Day Fentanyl Citrate Patch in Japanese Pediatric and Adolescent Patients with Cancer Pain. (PubMed, Clin Drug Investig) - "Fentanyl citrate patch tended to result in a higher serum fentanyl concentration in pre-school patients than in school-aged, adolescent, and adult patients who received the same dose. The patch provided adequate pain control, was well tolerated, and did not cause respiratory adverse events."

Clinical • Journal • PK/PD data • Oncology • Pain • Pediatrics

Efficacy and Safety of Fentanyl Citrate Patch, Including a Low-Dose 0.5 mg Formulation, in Opioid-Naïve Patients with Cancer Pain. (PubMed, Clin Drug Investig) - "A low-dose fentanyl citrate patch was effective in the management of cancer pain in opioid-naïve patients and was well tolerated."

Clinical • Journal • CNS Disorders • Depression • Oncology • Pain • Psychiatry • Renal Disease

Observational Study Investigating the Effectiveness of Fentanyl Matrix in Relieving Pain and Improving Function in Patients With Osteoarthritis of the Knee or Hip (clinicaltrials.gov) - P4; N=742; Completed; Sponsor: Janssen Korea, Ltd., Korea; Phase classification: P=N/A -> P4

Phase classification • Biosimilar • Immunology • Osteoarthritis • Pain

The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl (clinicaltrials.gov) - P=N/A; N=0; Withdrawn; Sponsor: Northwestern University; Not yet recruiting -> Withdrawn

Trial withdrawal • Biosimilar • Dyslipidemia

The Effect of Ketamine in the Prevention of Hypoventilation in Patients Undergoing Deep Sedation Using Propofol and Fentanyl (clinicaltrials.gov) - P=N/A; N=0; Withdrawn; Sponsor: Northwestern University

Trial initiation date • Biosimilar

Hisamitsu Pharmaceutical Co., Inc.Q2 FY02/2012 results (Hisamitsu) - Regulatory submission in Japan planned in FY 13

Anticipated filing in Japan • Pain

Drugs for ventilated patients in short supply - "Steven Lucio...said in an interview Thursday, that with some drugs like blood pressure medications there are numerous options available for physicians and pharmacists to choose from when treating patients. That is not the case when it comes to the medications needed to keep ventilated patients remain calm and sedated. 'If you are on a ventilator and you don't have fentanyl, you are really putting physicians, nurses and pharmacists in a tough position,' Lucio said. 'And what is the impact, the outcomes for the patient? That is the most important thing.'"

Media quote

"#KyowaKirin Announces an Partial Change Approval Application of #FENTOSTAPE (Code: #HFT290) Submission by #HisamitsuPharmaceutical in Japan https://t.co/B7yX83f9MV" (@1stOncology)