A Multicentric, Open-label, Randomized, Two Treatment, Two Sequence, Two Period, Crossover, Steady state Bioequivalence Study of Vigabatrin 500 mg Immediate-Release Tablets of Aucta Pharmaceuticals, LLC (Test) With SABRIL (Vigabatrin) Tablets 500mg of Lundbeck Pharmaceuticals LLC, USA (Reference) in adult refractory complex partial-seizure/ focal epilepsy patients who are already on established Vigabatrin adjunctive therapy under fasting conditions.

Start Date25 Aug 2020

Sponsor / Collaborator

Aucta Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Aucta Pharmaceuticals, Inc.

0 Patents (Medical) associated with Aucta Pharmaceuticals, Inc.

Literatures (Medical) associated with Aucta Pharmaceuticals, Inc.

01 May 2024·Epilepsy research

Lacosamide extended-release capsules are bioequivalent to lacosamide immediate-release tablets: Pharmacokinetic observations and simulations

Article

Author: Tan, Marie ; Chang, Wilson ; Gong, Lixin ; Lyu, Shaoqiong ; Zheng, Xun ; Gidal, Barry ; Li, Rong ; Wheless, James

OBJECTIVES:

Assess the bioequivalence of lacosamide extended-release (XR) capsules and immediate-release (IR) tablets and answer real-world clinical questions regarding the use of lacosamide XR.

METHODS:

An open-label, randomized, two-treatment, two-sequence, oral comparative bioavailability study was conducted to assess the bioequivalence of two lacosamide formulations. Participants were randomized 1:1 to receive lacosamide XR capsules (400 mg once-daily) or IR tablets (200 mg twice-daily) in 1 of 2 sequences over 7-day periods. Primary outcome was the area under the lacosamide concentration-time curve over 24 h at steady-state (AUC_0-τ,ss). Secondary outcomes were maximum (C_max,ss) and minimum concentrations at steady-state (C_min,ss). Bioequivalence was established when 90% confidence intervals (CIs) for geometric least square means ratios (GLSMs) were between 80% and 125%. Adverse events (AEs) and other safety outcomes were also assessed. Pharmacokinetic simulations, including adherent and partially adherent dosing scenarios with XR and IR formulations, modeled the clinical use of lacosamide XR.

RESULTS:

Thirty-five healthy adult males were enrolled in the bioequivalence study. After 7 days of study drug, mean AUC_0-τ,ss, C_max,ss, and C_min,ss values were similar between XR and IR formulations; all 90% CIs for GLSMs were between 80% and 125%. AEs were mild and no serious AEs or other clinically significant safety findings were observed. Pharmacokinetic simulations suggested that partial adherence affected formulations similarly; and the best strategy for switching formulations was to take the morning lacosamide IR dose followed by the evening lacosamide XR dose, as this resulted in the most consistent lacosamide plasma concentrations.

CONCLUSIONS:

Once-daily lacosamide XR capsules were bioequivalent to twice-daily lacosamide IR tablets. Pharmacokinetic simulations indicated lacosamide XR and IR formulations were similarly affected by partial adherence, though once-daily dosing with lacosamide XR may offer clinical advantages, and formulations can be easily switched. These results support the use of lacosamide XR capsules as a once-daily alternative to lacosamide IR tablets.

01 Jan 2019·Cancer informatics

Identification of Targetable Pathways in Oral Cancer Patients via Random Forest and Chemical Informatics

Article

Author: Schomberg, John

Treatment of head and neck cancer has been slow to change with epidermal growth factor receptor (EGFR) inhibitors, PD1 inhibitors, and taxane-/plant-alkaloid-derived chemotherapies being the only therapies approved by the U.S. Food and Drug Administration (FDA) in the last 10 years for the treatment of head and neck cancers. Head and neck cancer is a relatively rare cancer compared to breast or lung cancers. However, it is possible that existing therapies for more common solid tumors or for the treatment of other diseases could also prove effective against oral cancers. Many therapies have molecular targets that could be appropriate in oral cancer as well as the cancer in which the drug gained initial FDA approval. Also, there may be targets in oral cancer for which existing FDA-approved drugs could be applied. This study describes informatics methods that use machine learning to identify influential gene targets in patients receiving platinum-based chemotherapy, non-platinum-based chemotherapy, and genes influential in both groups of patients. This analysis yielded 6 small molecules that had a high Tanimoto similarity (>50%) to ligands binding genes shown to be highly influential in determining treatment response in oral cancer patients. In addition to influencing treatment response, these genes were also found to act as gene hubs connected to more than 100 other genes in pathways enriched with genes determined to be influential in treatment response by a random forest classifier with 20 000 trees trying 320 variables at each tree node. This analysis validates the use of multiple informatics methods to identify small molecules that have a greater likelihood of efficacy in a given cancer of interest.

Using systems biology in computational drug design workflows

Author: Nicola, George ; Kovacs, Bruce

We have built an automated, workflow-based system that predicts mechanism of action for new indications of safe, off-patent drugs.The platform technol. can also design new mols. for a known target or an active drug program.We do this through a combination of enumerating derivatives from a patent, generating a combinatorial library of analogs around a Markush scaffold, chem. fingerprint searches, 3D similarity (shape, pharmacophores, electrostatics), ADMET descriptor matching, gene expression profiling, and protein docking.The platform is built in the KNIME workflow environment, and uses both open source as well as proprietary software.The prediction algorithm is custom designed using machine learning models that have been trained on large data sets.We connect and make use of multiple web-accessible databases including those for binding activity, chem. and protein structures, biol. pathways, and gene expression.To feed compounds into the workflow, we have also built a comprehensive compound registration system that analyses, isomerizes, de-duplicates, and uploads compounds to an Instant JChem-enabled MySQL database server.Our base library consists of 10,000 com. available drug compounds, as well as several hundred hand-picked compounds with known activities.Our workflow-based platform technol. has proven especially useful when partnering with small and mid-size pharmaceutical companies seeking to address an unmet medical need by redesigning an existing product, and where regulatory approval is likely to be achieved rapidly.We provide an example of this platform being used successfully to repurpose an antipsychotic mol. into a drug candidate currently in Phase III clin. trials.We are currently in the process of designing better mol. analogs for this project.

News (Medical) associated with Aucta Pharmaceuticals, Inc.

26 Feb 2024

·www.prnewswire.com

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide

PISCATAWAY, N.J., Feb. 26, 2024 /PRNewswire/ -- Aucta Pharmaceuticals, Inc., a private specialty pharmaceutical company focused on niche generic and branded specialty products, today announced the commercial launch of MOTPOLY XR (lacosamide) extended-release capsules C-V (100, 150 and 200 mg). MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg. MOTPOLY XR is bioequivalent to Vimpat® (lacosamide) film-coated tablets, C-V and provides a new once-daily option at equivalent doses. It will be available through retail pharmacies. "MOTPOLY XR marks a major milestone for Aucta as our 1st branded pharmaceutical product to enter the US market. It will be supported by a full commercial infrastructure including field and inside sales, managed care and formulary access support, and a copay savings program," said Shoufeng Li, PhD., CEO of Aucta Pharmaceuticals. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Antiepileptic drugs increase the risk of suicidal behavior and ideation. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors. MOTPOLY XR may cause dizziness and ataxia in patients. Advise patients not to operate machinery or motor vehicles until they know how MOTPOLY XR affects them. Obtain ECG before beginning MOTPOLY XR, and after titration to steady-state maintenance dose in patients with underlying proarrhythmic conditions or those on concomitant medications that affect cardiac conduction. Closely monitor these patients. MOTPOLY XR may cause syncope in patients. Gradually withdraw MOTPOLY XR to minimize the potential of increased seizure frequency. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/multi-organ hypersensitivity has been reported and can be life-threatening or fatal. If signs or symptoms are present, immediately evaluate the patient. Discontinue MOTPOLY XR if there is no alternative etiology. MOST COMMON ADVERSE REACTIONS The most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence. PREGNANCY: Based on animal data, MOTPOLY may cause fetal harm. DRUG INTERACTIONS: Consider dose reduction in patients with renal or hepatic impairment taking strong inhibitors of CYP3A4 and CYP2C9. To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or . For more information, please visit and please see full Prescribing Information. About Aucta Pharmaceuticals, Inc. Aucta Pharmaceuticals, Inc. is a research and technology-based pharmaceutical company focusing on the development and commercialization of niche generic and branded specialty products. The company's corporate strategy is to focus on proven molecules, and, through innovation, create new therapeutics with lower scientific risk that fulfill unmet medical needs. Its specialty division has a therapeutic focus in CNS, Inhalation, Ophthalmics, and Other Specialty fields. For more information, visit . Vimpat® is a registered trademark used under license from Harris FRC corporation. SOURCE Aucta Pharmaceuticals, Inc.

Drug Approval

01 Dec 2022

·www.prnewswire.com

Aucta announces FDA approval of a generic version of Perforomist® (Formoterol Fumarate) Inhalation Solution

PISCATAWAY, N.J., Dec. 1, 2022 /PRNewswire/ -- Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals"), announced today the U.S. approval of a generic version of Perforomist®[1] (formoterol fumarate) Inhalation Solution. Formoterol fumarate inhalation solution had annual sales in the U.S. exceeding $268 million in the aggregate for the 12-month period ending September 2022 according to available data from IQVIATM. Brian Zorn, Chief Commercial Officer of Aucta Pharmaceuticals stated, "We are pleased to have our third Aucta Pharmaceuticals-developed product approved for the U.S. market. This marks the launch of our new commercial infrastructure to commercialize this and future products in the U.S." Please see full Prescribing Information available at . About Aucta Pharmaceuticals, Inc. Aucta Pharmaceuticals, Inc. is a research and technology based pharmaceutical company focusing on the development and commercialization of niche generic and branded specialty products. The company's corporate strategy is to focus on proven molecules, and, through innovation, create new therapeutics with lower scientific risk that fulfill unmet medical needs. Its specialty division has a therapeutic focus in CNS, Ophthalmology, Respiratory and Other Specialty fields. For more information, visit . SOURCE Aucta Pharmaceuticals, Inc.

Drug Approval

100 Deals associated with Aucta Pharmaceuticals, Inc.

100 Translational Medicine associated with Aucta Pharmaceuticals, Inc.

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Lacosamide ( Sodium channels )	Epilepsies, Partial More	Approved
AUC025A	Nervous System Diseases More	NDA/BLA
UAP-028B	Eye Diseases More	Preclinical
UAP-041	Nervous System Diseases More	Preclinical
UAP-009C	Nervous System Diseases More	Preclinical

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