February 2021 – Drug and Device Digest

Marketing Authorizations: TALUS SPACER for ankle avascular necrosis, eXciteOSA for mild obstructive sleep apnea, COSELA for chemotherapy-induced myelosuppression

Patient Specific TALUS SPACER

Additive Orthopaedics, LLC.

INDICATION FOR USE: For avascular necrosis (AVN)of the ankle joint

The anatomical landmarks necessary for the design and creation of the Spacer must be present and identifiable on computed tomography scan

ADDRESSING UNMET NEED:

  • AVN is a rare condition that causes the death of bone tissue due to lack of blood supply
  • Implant provides joint-sparing alternative to other surgical interventions commonly used in late-stage AVN

DESCRIPTION:

  • Solid, polished replica of the patient’s bone to allow patient to regain motion and reduce pain without amputation
  • Implant is 3D printed in CoCr using a laser sintering platform
  • All surfaces of the device are hand polished to a mirror finish
  • Implant is cleaned and passivated per ASTM A967 and will be sterilized by the end user via steam sterilization.
  • Creation of a patient-specific device is achieved via computed tomography (CT) scanning and CAD/CAM generation
  • No specific instruments are provided with the subject device

SAFETY & PROBABLE BENEFIT:

  • 31 patients and 32 talus replacement surgeries (one patient had operations on both ankles) with the implant
  • Primary probable benefit endpoint: Reduction in baseline level pain following surgery using the Visual Analog Scale (“VAS”) for pain; secondary endpoints of ankle range of motion, Foot and Ankle Outcome Scores
  • Improvement in scores after surgery with further improvement 2 and 3 years after surgery
  • Few safety events : Pain and scare tissue; most significant risk is reoperation

REGULATORY PATHWAY: Humanitarian Device Exemption

  • Humanitarian Use Designation (HUD); intended to benefit patients for condition that affects not more than 8,000 individuals in the U.S. per year
  • Post-Approval Study (PAS) is a prospective post-approval US registry study to provide ongoing safety and probable benefit assessment

LABELING

eXciteOSA 

Signifier Medical Technologies, LLC.

INTENDED USE: For the reduction of snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation

INDICATIONS FOR USE: For use to reduce snoring and mild sleep apnoea (AHI<15) for patients that are 18 years or older

ADDRESSING UNMET NEED:

  • OSA has potential serious long-term effects such as heart attack, glaucoma, diabetes, cancer and cognitive and behavioral disorders
  • First device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep

DESCRIPTION:

  • Removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue
  • Through a mouthpiece that sits around the tongue; has four electrodes, two located above the tongue and two located below the tongue
  • Provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between
  • Used for 20 minutes once a day during a wakeful state, for a period of 6‐weeks, and once a week thereafter

EFFECTIVENESS & SAFETY:

  • Clinical study, n= 115 patients with snoring, including 48 patients with snoring and mild OSA
  • Endpoint: 20% time reduction in snoring at levels > 40dB in 87 patients, 48% reduction in Apnea-Hypopnea Index in 41 patients with OSA
  •  Most common adverse events: Excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw
  • Patients should receive a comprehensive dental examination prior to use of the device

REGULATORY PATHWAY: De Novo classification

USER GUIDE

COSELA (trilaciclib) injection

G1 Therapeutics

INDICATION FOR USE: To decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan containing regimen for extensive-stage small cell lung cancer (ES-SCLC)

ADDRESSING UNMET NEED:

  • Protecting bone marrow function may help make their chemotherapy for ES-SCLC safer and improve treatment compliance
  • Treatment option can reduce the occurrence of a common, harmful side effect of chemotherapy

MECHANISM OF ACTION: Transient inhibitor of CDK 4 and 6. Hematopoietic stem and progenitor cells
(HSPCs) in the bone marrow give rise to circulating neutrophils, RBCs, and platelets. HSPC proliferation is dependent on CDK4/6 activity

EFFICACY & SAFETY:

  • Three randomized, double-blind, placebo-controlled trials, n=245 patients, COSELA vs placebo
  • Primary endpoint: Proportion of patients with severe neutropenia and duration of severe neutropenia in the first cycle of chemotherapy
  • COSELA resulted in lower chance of severe neutropenia vs, placebo; also reduced duration of sever neutropenia
  • Most common side effects: Fatigue; low levels of calcium, potassium and phosphate; increased levels of an enzyme called aspartate aminotransferase; headache; and infection in the lungs (pneumonia)
  • Patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis (lung tissue inflammation) and embryo-fetal toxicity

REGULATORY PATHWAY: NDA

  • Priority Review and Breakthrough Therapy designations

LABEL


Image credit: Additive Orthopaedics, Signifier Medical, G1 Therapeutics

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