American College of Clinical Pharmacology

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary,

Founded in 1969 by a group of eminent physicians, the College today consists of a full spectrum of healthcare professionals who remain dedicated to advancing clinical pharmacology with the goal of providing exceptional patient care.

As an organization whose primary role is education, the College does not concentrate on any one aspect of the discipline. Rather, the College seeks to address the educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans. These areas include, but are not limited to, pharmaceutical chemistry, biochemistry, drug metabolism, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenomics, clinical pharmacology practice in the outpatient and inpatient settings, human toxicology, drug interactions, and clinical drug trials. The diversity of the College is expressed not only in the composition of its membership, but also in its leadership. Maintaining a balance of elected Regents and Officers from all pertinent professional backgrounds ensures that the College remains attuned to the needs of all professionals engaged in the practice of or with a strong interest in clinical pharmacology, from the research laboratory (academic and industrial) to the classroom, and from the clinical trial to improved patient care.

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary, accredited Continuing Education programs, publications, networking and other career-enhancing opportunities to a wide spectrum of health care professionals using clinical pharmacology in disciplines from research to patient care.

Mission: Vision & Mission To improve health by optimizing therapeutics. Provide innovative leadership and interdisciplinary education that will enable the generation, integration and translation of scientific knowledge to optimize research, development and utilization of medication for the benefit of all.

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"Pediatric Inflammatory Bowel Disease (IBD) Workshop" jointly sponsored by the Food and Drug Administration (FDA) and the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

Date: Friday, November 16, 2018
Time: 8:30 AM to 5:00 PM ET
Location: FDA's White Oak Campus, 10903 New Hampshire Avenue, Building #31 - Room 1503A, Silver Spring, MD 20903

*Goals and Objectives*
The workshop will discuss current barriers to expeditious pediatric IBD drug development and steps to overcome them. Specific topics will include a review of the legislation relevant to pediatric trials, extrapolation, trial design considerations, dose selection and the level of evidence required to establish safety and effectiveness
http://bit.ly/2pVPP2Q

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www.accessdata.fda.gov

FDA Approves NUZYRA (Omadacycline) for Community-Acquired Bacterial Pneumonia and for Acute Bacterial Skin and Skin Structure Infections in Adults

On October 2, 2018, the U.S. Food and Drug Administration (FDA) approved NUZYRA (omadacycline) for the treatment of adult's patients with the following infections caused by susceptible microorganisms:

• Community-acquired bacterial pneumonia (CABP)

• Acute bacterial skin and skin structure infections (ABSSSI)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

The approved recommended dosage of NUZYRA for CABP and ABSSSI is shown below:
• CABP: Loading dose on day 1 is 200 mg by intravenous (IV) infusion over 60 minutes OR 100 mg by IV infusion over 30 minutes twice. NUZYRA maintenance dosage for CABP is 100 mg by IV infusion over 30 minutes once daily OR 300 mg orally once daily.

• ABSSSI: Loading dose on day 1 is 200 mg by IV infusion over 60 minutes OR 100 mg by IV infusion over 30 minutes twice. NUZYRA maintenance dosage for ABSSSI is 100 mg by IV infusion over 30 minutes once daily OR 300 mg orally once daily.

• ABSSSI (tablets only): Loading dose on day 1 and day 2 is 450 mg orally once daily and the maintenance dosage is 300 mg orally once daily.

NUZYRA treatment duration for CABP and ABSSSI is 7 to 14 days.

When administering NUZYRA tablets ensure that the patient fasts for at least 4 hours and then takes NUZYRA tablets with water. After oral dosing, no food or drink (except water) is to be consumed for 2 hours and no dairy products, antacids, or multivitamins for 4 hours. Do NOT administer NUZYRA for injection with any solution containing multivalent cations, e.g., calcium and magnesium, through the same intravenous. Co-infusion with other medications has not been studied.

Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality. The use of NUZYRA may cause permanent discoloration of the teeth and enamel hypoplasia, inhibition of bone growth, and clostridium difficile-associated diarrhea.

Additional information regarding dosage and administration and important warnings and precautions, including a mortality imbalance, can be found in the full prescribing information linked below.

*Mechanism of Action (MOA) and Pharmacokinetics (PK)*
• MOA: NUZYRA is a tetracycline class antibacterial drug.

• General PK: Following single oral doses of NUZYRA 300 to 450 mg in healthy subjects resulted in dose proportional increases in omadacycline Cmax and AUC. The mean accumulation ratio of NUZYRA was 1.5.

• Absorption: The bioavailability is 34.5% following a single 300 mg dose of NUZYRA. The median Tmax of NUZYRA for 100 mg IV dose is 0.55 hour and for 300 mg and 450 mg oral doses is 2.5 hours.

• Distribution: Protein binding of omadacycline is 20% and is not concentration dependent. The mean (%CV) volume of distribution of omadacycline at steady state following IV administration of NUZYRA 100 mg was 190 (27.7) L.

• Elimination: The mean elimination half-life of omadacycline at steady state is 16, 15.5, and 16.83 hours for NUZYRA 100 mg IV, 300 mg oral and 450 mg oral dosages, respectively.

• Metabolism: In vitro studies using human liver microsomes and hepatocytes demonstrated that omadacycline is not metabolized.

• Excretion: Following a 100 mg IV dose of NUZYRA, 27% of the dose was recovered as unchanged omadacycline in the urine. In healthy male volunteers receiving 300 mg oral radiolabeled omadacycline, 77.5% to 84% of the dose was recovered in the feces, approximately 14.4% (range 10.8% to 17.4%) in the urine, with 95.5% of the administered dose recovered after 7 days.

• Lactation: Breastfeeding is not recommended during treatment in NUZYRA and for 4 days (based on half-life) after the last dose.

*Drug Interactions*
• Anticoagulant Drugs: Tetracyclines have shown to depress plasma prothrombin activity. Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while also taking NUZYRA.

• Antacids and Iron Preparations: Absorption of oral tetracyclines, including NUZYRA, is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate, and iron containing preparations.

*Use in Specific Populations*
No clinically significant differences in the pharmacokinetics of omadacycline were observed based on age, sex, race/ethnicity, weight, renal impairment, end-stage renal disease, or hepatic impairment.

*Efficacy and Safety*
Efficacy of NUZYRA was demonstrated in a multinational, double-blind, double-dummy trial comparing NUZYRA to moxifloxacin in adults with CABP. Efficacy of NUZYRA was demonstrated in two multicenter, multinational, double-blind, double dummy trials in adults with ABSSSI which compared NUZYRA to linezolid. The ABSSSI trials enrolled patients with cellulitis, major abscess, or wound infection. Additional information regarding efficacy trial(s) can be found in the full prescribing information linked below.

Most common adverse reactions (incidence ≥ 2%) includes nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
________________________________________
Full prescribing information is available at https://go.usa.gov/xPku9.

Visit [email protected] at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.
A non-comprehensive list of examples of clinical substrates, inhibitors and inducers for metabolic and transporter system related interactions may be found at https://go.usa.gov/xXY9C.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of information you receive via this burst email initiative. Comments may be sent via email to [email protected].

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#TakeBackDay - October 27, 2018
The DEA Take Back Day initiative provides individuals with the opportunity to dispose of their unused or expired prescription drugs to help prevent the abuse of medications. Find a local collection site near you: http://bit.ly/2pNLbUt

Clinical Pharmacology in Drug Development, Oct 2018 Volume 7, Issue 7 now available!

*Articles*
Tracking the Sugar Rush: Incorporating Continuous Glucose Monitoring Into Multisite Early Clinical Research With Type 2 Diabetes Subjects
Sabina Paglialunga, Bruce H. Morimoto, Amparo de la Peña, Caroline Fortier
Pages: 676-683 | First Published: 14 February 2018

A Pharmacokinetic Study of an Ibuprofen Topical Patch in Healthy Male and Female Adult Volunteers
Fraser Lewis, Mark P. Connolly, Aomesh Bhatt
Pages: 684-691 | First Published: 11 January 2018

Population Pharmacokinetics of Levofloxacin in Plasma and Bone of Patients Undergoing Hip or Knee Surgery
Ulrich Gergs, Dorothea Ihlefeld, Tobias Clauss, Michael Weiss, Klaus Pönicke, Gunther O. Hofmann, Joachim Neumann
Pages: 692-698 | First Published: 18 December 2017

Bioavailability and Pharmacokinetics of TRPV1 Antagonist Mavatrep (JNJ-39439335) Tablet and Capsule Formulations in Healthy Men: Two Open-Label, Crossover, Single-Dose Phase 1 Studies
Prasarn Manitpisitkul, Kevin Shalayda, Lucille Russell, Panna Sanga, Yinka Williams, Bhavna Solanki, Joseph Caruso, John A. Moyer
Pages: 699-711 | First Published: 10 November 2017

Pharmacokinetics and Safety of Mavatrep (JNJ-39439335), a TRPV1 Antagonist in Healthy Japanese and Caucasian Men: A Double-Blind, Randomized, Placebo-Controlled, Sequential-Group Phase 1 Study
Prasarn Manitpisitkul, Kevin Shalayda, Lucille Russell, Panna Sanga, Bhavna Solanki, Joseph Caruso, Yuki Iwaki, John A. Moyer
Pages: 712-726 | First Published: 10 November 2017

Evaluation of Eluxadoline Effect on Cardiac Repolarization
Laura Bonifacio, Thomas L. Hunt, Gail McIntyre, Leonard S. Dove, Paul S. Covington
Pages: 727-736 | First Published: 16 April 2018

Effects of Milk or Apple Juice Ingestion on the Pharmacokinetics of Elvitegravir and Cobicistat in Healthy Japanese Male Volunteers: A Randomized, Single-Dose, Three-Way Crossover Study
Takuma Yonemura, Nozomi Okada, Koichi Sagane, Kazuhiro Okamiya, Hideki Ozaki, Toshiaki Iida, Hiroyuki Yamada, Hiroki Yagura
Pages: 737-743 | First Published: 24 January 2018

Odanacatib Pharmacokinetics Comparison Between Chinese and Non-Chinese Postmenopausal Women
Xia Chen, Ji Jiang, Pei Hu, Stefan Zajic, Wen Liu, Jacqueline McCrea, Fang Liu, Rose Witter, Eric Mangin, S. Aubrey Stoch
Pages: 744-750 | First Published: 14 February 2018

Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology
Jacob Atsmon, Daphna Heffetz, Lisa Deutsch, Frederic Deutsch, Hagit Sacks
Pages: 751-758 | First Published: 10 November 2017

Evaluation of the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy After Single and Multiple Dosings of LY3016859 in Healthy Subjects and Patients With Diabetic Nephropathy
Joanne Sloan-Lancaster, Eyas Raddad, Mark A. Deeg, Michelle Eli, Amy Flynt, James Tumlin
Pages: 759-772 | First Published: 31 January 2018

Pharmacologic and Pharmacodynamic Equivalence of 2 Formulations of Orlistat
Steven Johnson, Susan M. Schwartz
Pages: 773-780 | First Published: 16 April 2018

Pharmacokinetics and Target Attainment of Ceftobiprole in Asian and Non-Asian Subjects
A. E. Muller, N. Punt, M. Engelhardt, A. H. Schmitt-Hoffmann, J. W. Mouton
Pages: 781-787 | First Published: 16 May 2018

*Brief Report*
Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate in Elderly Subjects
Shawn D. Flanagan, Sonia L. Minassian, Philippe Prokocimer
Pages: 788-794 | First Published: 10 January 2018
#ACCPCPPD http://bit.ly/2QAr5Zp

www.accessdata.fda.gov

FDA Approves SEYSARA (Sarecycline) for Inflammatory Lesions of Non-Nodular Moderate to Severe Acne Vulgaris in Patients 9 Years of Age and Older

On October 1, 2018, the U.S. Food and Drug Administration (FDA) approved SEYSARA (sarecycline), a tetracycline-class drug, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. The approved recommended dosage of SEYSARA is once daily with or without food as shown below:

• 60 mg for patients who weigh 33-54 kg
• 100 mg for patients who weigh 55-84 kg
• 150 mg for patients who weigh 85-136 kg

Administer SEYSARA with adequate amounts of fluid to reduce the risk of esophageal irritation and ulceration. Efficacy of SEYSARA beyond 12 weeks and safety beyond 12 months have not been established. If there is no improvement after 12 weeks, reassess treatment with SEYSARA. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, SEYSARA should be used only as indicated. SEYSARA has not been evaluated in the treatment of infections.

Mechanism of Action (MOA) and Pharmacokinetics (PK)

• MOA: The mechanism of action of SEYSARA in treating acne vulgaris is not known.

• General PK: Increasing the SEYSARA dose from 60 to 150 mg once daily in healthy subjects resulted in a slightly less than proportional increase in sarecycline steady-state Cmax and AUCtau. A mean accumulation ratio of sarecycline ranges from 1.5- to 1.6-fold with repeated dosing. Steady-state of sarecycline was reached by Day 7.

• Absorption: The median Tmax of sarecycline is 1.5 to 2.0 hours.

• Distribution: Protein binding of sarecycline is 62.5% to 74.7% in vitro. The mean apparent volume of distribution of sarecycline at steady-state ranges from 91.4 L to 97.0 L.

• Elimination: The mean apparent oral clearance (CL/F) of sarecycline at steady state is approximately 3 L/h. The mean elimination half-life of sarecycline is 21 to 22 hours.

• Metabolism: Metabolism of sarecycline by enzymes in human liver microsomes is < 15% in vitro.

• Excretion: After a single 100 mg oral dose of radiolabeled sarecycline, 42.6% of the dose was recovered in feces (14.9% as unchanged) and 44.1% in urine (24.7% as unchanged).

Drug Interactions

• Oral Retinoids: Tetracyclines may cause increased intracranial pressure as do oral retinoids, including isotretinoin and acitretin. Avoid coadministration of SEYSARA with oral retinoids.

• Antacids and Iron Preparations: Coadministration with antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations may impair absorption of SEYSARA, similar to other tetracyclines, which may decrease its efficacy. Separate dosing of SEYSARA from antacids containing aluminum, calcium or magnesium, bismuth subsalicylate, and iron-containing preparations.

• Penicillin: Similar to other tetracycline, SEYSARA may interfere with the bactericidal action of penicillin. Avoid coadministration of SEYSARA with penicillin.

• Anticoagulants: Similar to other tetracyclines, SEYSARA may depress plasma prothrombin activity, which may increase the risk of bleeding in patients who are on anticoagulant therapy. Decrease anticoagulant dosage when coadministered with SEYSARA as appropriate.

• P-glycoprotein (P-gp) Substrates: Concomitant use of SEYSARA may increase concentrations of P-gp substrates (e.g., digoxin). Monitor for toxicities, and dosage reduction may be required for drugs that are P-gp substrates when used concomitantly with SEYSARA.

Use in Specific Populations

No clinically significant differences in the pharmacokinetics of sarecycline were observed based on age (11 to 73 years), weight (42 to 133 kg), sex, renal impairment, or mild to moderate hepatic impairment (Child Pugh A to B). The effect of end-stage renal disease (ESRD) or severe hepatic impairment (Child-Pugh C) on sarecycline pharmacokinetics has not been assessed.

Efficacy and Safety

Efficacy of once daily SEYSARA was assessed in two 12-week multicenter, randomized, double-blind, placebo-controlled studies in subjects 9 years of age and older. The two co-primary efficacy endpoints were the percentage of subjects with Investigator’s Global Assessment (IGA) success and absolute reduction from baseline in inflammatory lesion counts at Week 12. Additional information regarding efficacy trials can be found in the full prescribing information linked below.

Most common adverse reaction (incidence ≥ 1%) is nausea.
________________________________________
Full prescribing information is available at https://go.usa.gov/xPKdS.

Visit [email protected] at http://go.usa.gov/cMsjT for prescribing and patient information, approval letters, reviews and other information for FDA-approved drug products, which are often available shortly following approval.

A non-comprehensive list of examples of clinical substrates, inhibitors and inducers for metabolic and transporter system related interactions may be found at https://go.usa.gov/xXY9C.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), or by mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at http://go.fda.gov/subscriptionmanagement (note: this link does not work with Internet Explorer) and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to [email protected].

go.usa.gov

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