Galt Pharmaceuticals
GA - Atlanta
DiagnosticsFocus: Diagnostics for Osteoarthritis, Small Molecules
Galt Pharmaceuticals is a life sciences company focused on Diagnostics for Osteoarthritis, Small Molecules.
MusculoskeletalNeurology
Open Jobs
23
Products & Portfolio (3)
1 discontinued product not shown
ORAVIG
miconazole
LOE Approaching
SMBUCCAL · TABLET
12.1 Mechanism of Action Miconazole is an antifungal drug 12.3 Pharmacokinetics Absorption and Distribution Salivary Single dose application of ORAVIG containing 50 mg of miconazole to the buccal mucosa of 18 healthy volunteers provided mean maximum salivary concentrations of 15 mcg/mL at 7 hours after application of the tablet. This provided an average saliva exposure to miconazole estimated from the AUC (0-24h) of 55.23 mcg·h/mL. The pharmacokinetic parameters of miconazole in the saliva of healthy volunteers are provided in Table 4. Table 4: Pharmacokinetic (PK) Parameters of Miconazole in Saliva Following Application of a Single ORAVIG 50 mg Tablet in Healthy Volunteers (N = 18) Salivary PK Parameters (N = 18) Mean ± SD (Min - Max) AUC 0-24h (mcg-h/mL) 55.2 ±35.1 (0.5 – 128.3) C max (mcg/mL) 15.1 ±16.2 (0.5 – 64.8) T max (hour) 7* (2.0 – 24.1) *Median In healthy volunteers, the duration of buccal adhesion was on average 15 hours following a single dose application of ORAVIG 50 mg. Plasma Plasma concentrations of miconazole were below the lower limit of quantification (0.4 mcg/mL) in 157/162 (97%) samples from healthy volunteers following single-dose application of ORAVIG 50 mg. Measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL. Plasma concentrations of miconazole evaluated after 7 days of treatment in 40 HIV-positive patients were all below the limit of quantification (0.1 mcg/mL). Metabolism and Excretion Most of the absorbed miconazole is metabolized by the liver with less than 1% of the administered dose found unchanged in urine. In healthy volunteers, the terminal half-life is 24 hours following systemic administration. There are no active metabolites of miconazole. Food Effect There was no formal food effect study conducted with ORAVIG; however, in clinical studies patients were allowed to eat and drink while taking ORAVIG. 12.4 Microbiology Mechanism of Action Miconazole inhibits the enzyme cytochrome P450 14α-demethylase which leads to inhibition of ergosterol synthesis, an essential component of the fungal cell membrane. Miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes, increasing the amount of reactive oxygen species within the cell. Antimicrobial Activity Miconazole is active against Candida albicans, C. parapsilosis and C. tropicalis. Correlation between minimum inhibitory concentration (MIC) results in vitro and clinical outcome has yet to be established. Resistance In vitro studies have shown that some Candida strains that demonstrate reduced susceptibility to one antifungal azole may also exhibit reduced susceptibility to other azoles suggesting cross-resistance. Clinically relevant resistance to systemically utilized triazoles may occur in Candida species. Resistance may occur by multiple mechanisms such as changes in amino acids and/or in the regulation of the target enzyme and of a variety of efflux pump proteins. Multiple mechanisms may co‑ex
2010
30
ORPHENGESIC
orphenadrine citrate, aspirin and caffeine
Post-LOE
ORAL · TABLET
Cyclooxygenase Inhibitors
1998
30
ORPHENGESIC FORTE
orphenadrine citrate, aspirin and caffeine
Post-LOE
ORAL · TABLET
Cyclooxygenase Inhibitors
1998
30
Open Jobs (23)
Compliance Counsel (Fractional) *Remote*
Legal
1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, AMAT Pharmaceutics, LLC., for the Jamaica, NY territory
Jamaica, New York
Commercial1w ago
Business Development Representative (Pharmaceuticals): Columbus/Auburn, AL Territory
Auburn, Alabama
Commercial1w ago
Business Development Representative (Pharmaceuticals): Columbus/Auburn, AL Territory
Columbus, Georgia
Commercial1w ago
Business Development Representative (Pharmaceuticals)
Auburn, Alabama
Commercial1w ago
Specialty Pharmaceutical Sales Representative (Huntsville, AL Territory)
Huntsville, Alabama
Commercial1w ago
Specialty Pharmaceutical Sales Representative (Gadsden, AL Territory)
Gadsden, Alabama
Commercial1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, King Pharma USA, INC., for the Alpharetta, GA Territory
Alpharetta, Georgia
Commercial1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, King Pharma USA, INC., for the Stone Mountain, GA Territory
Stone Mountain, Georgia
Commercial1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, King Pharma USA, INC., for the Decatur, GA Territory
Decatur, Georgia
Commercial1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, King Pharma USA, INC., for the Roswell, GA Territory
Roswell, Georgia
Commercial1w ago
Regional Manager of Franchise Sales (Pharmaceutical Sales Experience Required)
Atlanta, Georgia
Commercial1w ago
Regional Manager of Franchise Sales (Pharmaceutical Sales Experience Required)
Tampa, Florida
Commercial1w ago
(Pharmaceutical Sales Experience Required) Regional Manager of Franchise Sales
Atlanta, Georgia
Supply Chain1w ago
(Pharmaceutical Sales Experience Required) Regional Manager of Franchise Sales
Tampa, Florida
Supply Chain1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, AMAT Pharmaceutics, LLC., for the NY territory
Forest Hills, New York
Commercial1w ago
Regional Manager of Franchise Sales
Atlanta, Georgia
Supply Chain1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, AG Pharmaceutics, LLC., for the Brooklyn, NY Territory
Brooklyn, New York
Commercial1w ago
Manager of Franchise Sales
Atlanta, Georgia
Supply Chain1w ago
Manager of Franchise Sales
Tampa, Florida
Supply Chain1w ago
Regional Manager of Franchise Sales
Tampa, Florida
Supply Chain1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, AMRX Pharma, LLC., for the Syosett Long Island, NY Territory
Hempstead, New York
Commercial1w ago
Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, AMRX Pharma, LLC., for the NY Territory
Hempstead, New York
Commercial1w ago
Interview Prep Quick Facts
Portfolio: 4 approved products
Top TAs: Musculoskeletal, Infectious Diseases, Psychiatry
Open Roles: 23 active jobs
Portfolio Health
LOE Approaching2 (50%)
Post-LOE2 (50%)
4 total products
Therapeutic Area Focus
Marketed
Pipeline
Hiring Trend
Actively Hiring
23
Open Roles
+23
Added
-0
Filled/Removed
Based on last 4 crawl cycles