Meeting With FDA Will Be Requested Before the End of 2015
LYON, France I June 29, 2015 I Flamel Technologies (NASDAQ: FLML) today announced positive results from two pilot pharmacokinetic (PK) studies in healthy volunteers of FT227, an abuse-deterrent, extended-release, oral hydromorphone product using its proprietary Trigger Lock™ drug delivery platform. Flamel’s Trigger Lock™ allows the development of abuse-deterrent extended release formulations of opioids and other drugs susceptible to abuse. Hydromorphone is used for relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.
The PK studies were intended to provide sufficient data for the Company to select a preferred prototype formulation to move forward into pivotal studies. The studies compared three FT227 prototypes to the comparator product Jurnista© (sold as Exalgo© in the United States) in both fasted and fed conditions at a dose of 32mg.
Under fasted conditions, comparing the area under the curve (AUC) and the peak plasma concentration (Cmax) of FT227 to Jurnista© in 16 subjects, the results identified a FT227 formulation that met the bioequivalence criteria for both parameters. Under fed conditions (14 subjects), the same formulation was bioequivalent in terms of AUC to Jurnista© but outside of the Cmax bioequivalence criterion at the lower confidence interval level. Comparing the effect of food on the PK parameters of the FT227 prototypes across the two studies, no notable difference is seen in either AUC or Cmax in fed and fasted conditions. This suggests that administration of FT227 will not be subject to a clinically relevant food effect.
In both studies FT227 was well tolerated and no serious adverse events were reported.
In addition, Flamel has generated substantial in vitro data comparing the abuse deterrence properties of FT227 compared to other marketed abuse-deterrent opioid products. The Company is confident that Trigger Lock™ is a robust platform for opioids that will set a high standard in terms of abuse deterrence. Further abuse deterrence data are being generated by an independent contract research organization and will be subject to further announcements. Flamel is planning to meet with the U.S. Food and Drug Administration (FDA) before the end of 2015 to discuss the remainder of the development plan for FT227. The product is designed to be filed as a 505(b)(2) New Drug Application (NDA). Based on current expectations, the selected formulation will be scaled-up over the coming months and the Company plans to begin pivotal registration studies by mid-2016.
“We are very pleased with these initial data on FT227 Trigger Lock™ and we are highly confident in our Trigger Lock™ abuse deterrent platform. We look forward to meeting with the FDA and to moving FT227 into pivotal studies in 2016,” said Mike Anderson, Chief Executive Officer.
As of December 2014, Trigger Lock™ is protected by seven Flamel patent application families, which expire between November 2025 and December 2033.
About Flamel Technologies – Flamel Technologies SA (NASDAQ: FLML) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs. Flamel currently has approvals for and markets two previously Unapproved Marketed Drugs (“UMDs”) in the USA, Bloxiverz™ (neostigmine methylsulfate injection) and Vazculep™ (phenylephrine hydrochloride injection). The Company intends to add to this branded business by creating additional products, focusing on the development of products utilizing Flamel’s proprietary drug delivery platforms. Flamel currently has several products in development utilizing Micropump® (oral sustained release microparticles platform) along with its tangent technologies, LiquiTime® and Trigger Lock™. The lead project for Micropump is Sodium Oxybate. LiquiTime allows for the extended-release of liquid medicines (such as Ibuprofen and Guaifenesin) and Trigger Lock is an abuse-resistant iteration of Micropump, designed specifically for long-acting opioids. Additionally, the Company has developed a long acting injectable platform, Medusa™, a hydrogel depot technology currently being studied with Exenatide. Flamel’s products are targeting high-value molecules and will utilize either the 505(b)(2) approval process for NDAs or biosimilar pathways ultimately approved by FDA and other regulatory authorities. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and Dublin, Ireland. Additional information may be found at www.flamel.com.
SOURCE: Flamel Technologies
Post Views: 33
Meeting With FDA Will Be Requested Before the End of 2015
LYON, France I June 29, 2015 I Flamel Technologies (NASDAQ: FLML) today announced positive results from two pilot pharmacokinetic (PK) studies in healthy volunteers of FT227, an abuse-deterrent, extended-release, oral hydromorphone product using its proprietary Trigger Lock™ drug delivery platform. Flamel’s Trigger Lock™ allows the development of abuse-deterrent extended release formulations of opioids and other drugs susceptible to abuse. Hydromorphone is used for relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.
The PK studies were intended to provide sufficient data for the Company to select a preferred prototype formulation to move forward into pivotal studies. The studies compared three FT227 prototypes to the comparator product Jurnista© (sold as Exalgo© in the United States) in both fasted and fed conditions at a dose of 32mg.
Under fasted conditions, comparing the area under the curve (AUC) and the peak plasma concentration (Cmax) of FT227 to Jurnista© in 16 subjects, the results identified a FT227 formulation that met the bioequivalence criteria for both parameters. Under fed conditions (14 subjects), the same formulation was bioequivalent in terms of AUC to Jurnista© but outside of the Cmax bioequivalence criterion at the lower confidence interval level. Comparing the effect of food on the PK parameters of the FT227 prototypes across the two studies, no notable difference is seen in either AUC or Cmax in fed and fasted conditions. This suggests that administration of FT227 will not be subject to a clinically relevant food effect.
In both studies FT227 was well tolerated and no serious adverse events were reported.
In addition, Flamel has generated substantial in vitro data comparing the abuse deterrence properties of FT227 compared to other marketed abuse-deterrent opioid products. The Company is confident that Trigger Lock™ is a robust platform for opioids that will set a high standard in terms of abuse deterrence. Further abuse deterrence data are being generated by an independent contract research organization and will be subject to further announcements. Flamel is planning to meet with the U.S. Food and Drug Administration (FDA) before the end of 2015 to discuss the remainder of the development plan for FT227. The product is designed to be filed as a 505(b)(2) New Drug Application (NDA). Based on current expectations, the selected formulation will be scaled-up over the coming months and the Company plans to begin pivotal registration studies by mid-2016.
“We are very pleased with these initial data on FT227 Trigger Lock™ and we are highly confident in our Trigger Lock™ abuse deterrent platform. We look forward to meeting with the FDA and to moving FT227 into pivotal studies in 2016,” said Mike Anderson, Chief Executive Officer.
As of December 2014, Trigger Lock™ is protected by seven Flamel patent application families, which expire between November 2025 and December 2033.
About Flamel Technologies – Flamel Technologies SA (NASDAQ: FLML) is a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs. Flamel currently has approvals for and markets two previously Unapproved Marketed Drugs (“UMDs”) in the USA, Bloxiverz™ (neostigmine methylsulfate injection) and Vazculep™ (phenylephrine hydrochloride injection). The Company intends to add to this branded business by creating additional products, focusing on the development of products utilizing Flamel’s proprietary drug delivery platforms. Flamel currently has several products in development utilizing Micropump® (oral sustained release microparticles platform) along with its tangent technologies, LiquiTime® and Trigger Lock™. The lead project for Micropump is Sodium Oxybate. LiquiTime allows for the extended-release of liquid medicines (such as Ibuprofen and Guaifenesin) and Trigger Lock is an abuse-resistant iteration of Micropump, designed specifically for long-acting opioids. Additionally, the Company has developed a long acting injectable platform, Medusa™, a hydrogel depot technology currently being studied with Exenatide. Flamel’s products are targeting high-value molecules and will utilize either the 505(b)(2) approval process for NDAs or biosimilar pathways ultimately approved by FDA and other regulatory authorities. The Company is headquartered in Lyon, France and has operations in St. Louis, Missouri, USA, and Dublin, Ireland. Additional information may be found at www.flamel.com.
SOURCE: Flamel Technologies
Post Views: 33
