FDA BRIEF: Week of March 6, 2017
NOCTIVA (desmopressin acetate) nasal spray
Marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC., USA
INDICATION: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. Nocturnal polyuria was defined in the NOCTIVA clinical trials as night-time urine production exceeding one-third of the 24-hour urine production
UNMET NEED: First therapeutic option to help reduce the number of times needed to wake up at night to urinate
REG PATHWAY: NDA, Division of Bone, Reproductive and Urologic Products, ODE III, CDER
- not approved for all causes of night-time urination
- health care providers need to confirm urine overproduction at night with a 24-hour urine collection
- Post-Marketing Requirement for PK study
- No REMS
MECHANISM OF ACTION: Synthetic analog of vasopressin; selective agonist at V2 receptors on renal cells in the collecting ducts, increasing water re-absorption in the kidneys, and reducing urine production
EFFICACY:
- Two 12-week randomized, doubleblind, trials, 6 mo. history of nocturic episodes, n=1,045, NOCTIVA vs, placebo
- Co-primary endpoints: (1) Change in mean nocturic episodes/night from baseline (2) % patients achieving at least 50% reduction in episodes from baseline
- Small reduction in average number of night-time urinations with NOCTIVA but more patients achieved 50% reduction in episodes
SAFETY:
- Boxed warning and Medication Guide for hyponatremia
- Most common side effects: Nasal discomfort, cold symptoms (nasopharyngitis), nasal congestion, sneezing, high or increased blood pressure, back pain, nose bleeds, bronchitis and dizziness.
AEROFORM Tissue Expander System
AirXpanders, Palo Alto, CA, USA
INDICATION FOR USE: For soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast. Intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
REG PATHWAY: De Novo Request
- Regulation Number: 21 CFR 878.3510
- Regulation Name: Carbon dioxide gas controlled tissue expander
- Regulatory Classification: Class II
- Product Code: PQN
GENERIC DEVICE TYPE: Carbon dioxide gas controlled tissue expander.
- Prescription device intended for temporary subcutaneous or submuscular implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage.
- Made of an inflatable elastomer shell and is filled with carbon dioxide gas.
- Utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the device.
RISKS & MITIGATIONS
- Pain from Overexpansion with Carbon Dioxide: Labeling, Software verification, validation and hazard analysis
- Tissue Damage from Overexpansion with Carbon Dioxide: In-vivo performance testing, Labeling, Software verification, validation and hazard analysis
- Prolonged Treatment Time: In-vivo performance testing, Non-clinical performance testing, Labeling, Software verification, validation and hazard analysis
- Re-operation: In-vivo performance testing, Non-clinical performance testing
- Underexpansion, Overexpansion, or No Expansion: Electromagnetic compatibility, electrical safety, and wireless compatibility testing, Labeling, Software verification, validation and hazard analysis, Human factors testing, Patient training
- Adverse Tissue Reaction: Biocompatibility evaluation
- Infection: Sterilization validation, Shelf life testing
CINtec Histology Kit
Ventana Medical Systems, Inc., Tucson, AZ, USA
INDICATION FOR USE: Qualitative immunohistochemistry (IHC) test using mouse monoclonal anti-p16 antibody clone E6H4, and is intended for use in the light microscopic assessment of the p16INK4a protein in formalin-fixed, paraffin-embedded (FFPE) cervical punch biopsy tissues using OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument. The test is indicated as an adjunct to examination of hematoxylin and eosin (H&E) stained slide(s), to improve consistency in the diagnosis of cervical intraepithelial neoplasia (CIN). Diagnosis of CIN presence or level should be based on H&E stained slide(s) and other clinical and laboratory test information
REG PATHWAY: De Novo Request
- Regulation Number: 21 CFR 864.1865
- Regulation Name: A cervical intraepithelial neoplasia (CIN) test system
- Regulatory Classification: Class II
- Product Code: PRB
GENERIC DEVICE DESCRIPTION: Cervical intraepithelial neoplasia (CIN) test system
- Used to detect biomarker associated with CIN in human tissues
- Adjunct test and not to be used as a stand-alone devic
- Results must be interpreted in the context of the patient’s clinical history including, but not limited to, prior and current cervical biopsy results, Papanicolaou (Pap) test results, human papillomavirus (HPV) test results, and morphology on hematoxylin and eosin (H&E) stained sections
- Not intended to detect the presence of HPV.
RISKS & MITIGATIONS:
- Inaccurate test results, such as false positive or false negative results: General and Special Controls
- Failure to correctly interpret test results can lead to false positive or false negative results: General and Special Controls