August 29, 2018

Our Therapies

Clinical Studies

Lyndra’s Extended Release Capsule Delivers Drug Consistently

Lyndra released clinical data in July 2020 at the 2020 Alzheimer’s Association International Conference demonstrating that two separate drugs can be delivered safely with predictable pharmacokinetics via its once-weekly dosage form. This was the first clinical study showing that it is possible to convert a once-daily combination therapy into a weekly dosage. It demonstrated controlled, steady release of medication over an extended period, something no oral therapy had previously achieved. The pharmacokinetics data also showed that an ultra-long-acting oral dosage form has the potential to reduce drug side effects often associated with the peaks as well as improve efficacy, often associated with the troughs seen in daily oral dosing.

  • Advantages in systemic, non-systemic, and local target delivery due to continuous & steady delivery
  • Possibility of reducing total dose while maintaining efficacy (non-inferiority)
  • Reducing Cmax has the potential to, or could improve side effects
  • Forgiveness if delayed administration
  • Reduced healthcare costs through better pharmacology and measurable health outcomes
  • Patient freedom from the burden of daily medications
  • Adaptable for wide range of single agents and combinations
  • Discreet user controlled administration
  • Reduced pill burden
  • Reduced caregiver burden
  • Superior Pharmacology for existing Agents
  • Loss of Exclusivity (LOE)
  • Combination Products
  • Local GI Delivery
  • Non-systemic Delivery Enhanced Continuous Release

Patients facing serious illnesses who have exhausted all available treatment options often want to know if and how they can receive early access to investigational drugs that haven’t yet been approved by government regulatory agencies. The information below explains options that may be available to patients in these circumstances. 

 

1. Clinical Trials 

For new medicines and vaccines to be legally approved for use, companies are required to evaluate their safety and effectiveness in clinical trials and submit trial results to regulatory agencies. To participate in a trial, you must meet certain criteria. For those who meet the criteria to join a clinical trial, participation offers the chance to contribute to medical research that may benefit many others. Participation in a clinical trial comes with certain risks and patient “informed consent” is a required step in the process of enrolling. 

For more information about Lyndra clinical trials, see Clinical Trials.Gov.

 

2. Pre-Approval Access 

When a clinical trial isn’t an option, and the patient has exhausted all available treatment options, there may be an opportunity for a treating physician to request an investigational drug pre-approval. Lyndra refers to these requests as pre-approval access. 

 

It’s important to remember that investigational drugs have not yet received regulatory approval.  Their potential risks and benefits are not yet established. Doctors and patients should consider all possible benefits and risks when seeking pre-approval access to an investigational drug. 

Request information about pre-approval access for a Lyndra investigational drug here

Lyndra's Pipeline

Research
Phase 1
Phase 2
Pivotal
Market
NEUROSCIENCE
LYN-005 Weekly Risperidone | Schizophrenia
LYN-157 Weekly Memantine / Donepezil | Alzheimer's Disease
LYN-014 Weekly Levomethadone | Opioid Use Disorder
CARDIOVASCULAR | METABOLIC DISEASES
LYN-047 Weekly Rosuvastatin | Dyslipidemia
LYN- 045 Weekly Dapagliflozin | Type 2 Diabetes
GLOBAL HEALTH
LYN-172 Weekly Undisclosed (Partnered) | HIV
LYN-163 Biweekly Ivermectin | Malaria Eradication
LYN-064 Monthly Oral Contraception | Women's Health

Lyndra has continued to expand its pipeline and recently completed the LYN-005 risperidone schizophrenia Phase 2 clinical study. Greater than 200 patients and healthy volunteers have participated in Lyndra’s clinical trials to date.   

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