ZP-Triptan Patch is Well-Tolerated and Achieves Rapid Absorption With Potential for Fast Relief Alternative for Migraine Patients
FREMONT, CA, USA I November 02, 2015 I Zosano Pharma Corporation (ZSAN), a clinical-stage specialty pharmaceutical company, today announced positive results from the Phase 1 clinical trial of its proprietary ZP-Triptan patch treatment for migraine.
ZP-Triptan is a zolmitriptan-coated microneedle patch that is applied to an individual’s upper arm to deliver zolmitriptan to the body. The objective of the Phase 1 clinical study was to evaluate the tolerability and pharmacokinetics of the ZP-Triptan patch in healthy volunteers. The crossover study among 20 healthy volunteers tested five doses of ZP-Triptan compared to an oral administration of zolmitriptan and additionally a subcutaneous injection of sumatriptan. ZP-Triptan demonstrated rapid absorption compared to the zolmitriptan tablet. All treatments were well tolerated and no safety issues were identified. The results for the sumatriptan injection were similar to those reported in the literature.
| |
|
Cmax (SD)
ng/ml |
|
Tmax (range)
minutes |
|
AUC0-2hr (SD)
ng/ml hour |
|
AUC0-last (SD)
ng/ml hour |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 0.48 mg |
|
1.8 (0.53) |
|
20 (2-30) |
|
2.1 (0.73) |
|
2.8 (1.36) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 2 x 0.48 mg |
|
3.7 (1.05) |
|
20 (2-30) |
|
4.2 (0.95) |
|
6.5 (1.97) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 1.9 mg |
|
6.8 (2.75) |
|
20 (2-30) |
|
7.4 (2.53) |
|
12.3 (4.31) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 2 x 1.9 mg |
|
14.6 (4.46) |
|
17.5 (2-30) |
|
16.4 (5.34) |
|
27.8 (9.93) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 3.8 mg |
|
22.6 (14.00) |
|
15 (2-30) |
|
19.3 (5.37) |
|
31.7 (8.35) |
| |
|
|
|
|
|
|
|
|
| Zolmitriptan Oral Tablet |
|
3.8 (1.51) |
|
60 (30-240) |
|
4.7 (2.24) |
|
22.2 (10.79) |
| |
|
|
|
|
|
|
|
|
Note: Mean values (median for Tmax) for the various zolmitriptan treatments are shown in the table above
“We are extremely pleased with the tolerability and pharmacokinetic results from our ZP-Triptan Phase 1 study,” said Thorsten von Stein, MD, PhD, Zosano Chief Medical Officer. “We expect that the demonstrated fast absorption will translate into fast pain relief. If so, ZP-Triptan’s fast absorption and simple injection-free administration may represent a strong product option for patients suffering from migraines. We look forward to discussing the program with the U.S. Food and Drug Administration (FDA) and to advancing clinical development.”
The company, which holds exclusive global rights to develop and commercialize the ZP-Triptan patch, intends to discuss further development plans with FDA and expects to initiate a Phase 2 clinical trial in 2016.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano Pharma’s microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano Pharma’s microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. Learn more at www.zosanopharma.com.
SOURCE: Zosano Pharma
Post Views: 100
ZP-Triptan Patch is Well-Tolerated and Achieves Rapid Absorption With Potential for Fast Relief Alternative for Migraine Patients
FREMONT, CA, USA I November 02, 2015 I Zosano Pharma Corporation (ZSAN), a clinical-stage specialty pharmaceutical company, today announced positive results from the Phase 1 clinical trial of its proprietary ZP-Triptan patch treatment for migraine.
ZP-Triptan is a zolmitriptan-coated microneedle patch that is applied to an individual’s upper arm to deliver zolmitriptan to the body. The objective of the Phase 1 clinical study was to evaluate the tolerability and pharmacokinetics of the ZP-Triptan patch in healthy volunteers. The crossover study among 20 healthy volunteers tested five doses of ZP-Triptan compared to an oral administration of zolmitriptan and additionally a subcutaneous injection of sumatriptan. ZP-Triptan demonstrated rapid absorption compared to the zolmitriptan tablet. All treatments were well tolerated and no safety issues were identified. The results for the sumatriptan injection were similar to those reported in the literature.
| |
|
Cmax (SD)
ng/ml |
|
Tmax (range)
minutes |
|
AUC0-2hr (SD)
ng/ml hour |
|
AUC0-last (SD)
ng/ml hour |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 0.48 mg |
|
1.8 (0.53) |
|
20 (2-30) |
|
2.1 (0.73) |
|
2.8 (1.36) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 2 x 0.48 mg |
|
3.7 (1.05) |
|
20 (2-30) |
|
4.2 (0.95) |
|
6.5 (1.97) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 1.9 mg |
|
6.8 (2.75) |
|
20 (2-30) |
|
7.4 (2.53) |
|
12.3 (4.31) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 2 x 1.9 mg |
|
14.6 (4.46) |
|
17.5 (2-30) |
|
16.4 (5.34) |
|
27.8 (9.93) |
| |
|
|
|
|
|
|
|
|
| ZP-Triptan 3.8 mg |
|
22.6 (14.00) |
|
15 (2-30) |
|
19.3 (5.37) |
|
31.7 (8.35) |
| |
|
|
|
|
|
|
|
|
| Zolmitriptan Oral Tablet |
|
3.8 (1.51) |
|
60 (30-240) |
|
4.7 (2.24) |
|
22.2 (10.79) |
| |
|
|
|
|
|
|
|
|
Note: Mean values (median for Tmax) for the various zolmitriptan treatments are shown in the table above
“We are extremely pleased with the tolerability and pharmacokinetic results from our ZP-Triptan Phase 1 study,” said Thorsten von Stein, MD, PhD, Zosano Chief Medical Officer. “We expect that the demonstrated fast absorption will translate into fast pain relief. If so, ZP-Triptan’s fast absorption and simple injection-free administration may represent a strong product option for patients suffering from migraines. We look forward to discussing the program with the U.S. Food and Drug Administration (FDA) and to advancing clinical development.”
The company, which holds exclusive global rights to develop and commercialize the ZP-Triptan patch, intends to discuss further development plans with FDA and expects to initiate a Phase 2 clinical trial in 2016.
About Zosano Pharma
Zosano Pharma Corporation is a clinical-stage specialty pharmaceutical company that has developed a proprietary transdermal microneedle patch system to deliver drug formulations through the skin for the treatment of a variety of indications. Zosano Pharma’s microneedle patch system offers rapid onset, consistent drug delivery, improved ease of use and room-temperature stability, benefits that the company believes often are unavailable using oral formulations or injections. Zosano Pharma’s microneedle patch system has the potential to deliver numerous medications for a wide variety of indications in commercially attractive markets. It has been tested in more than 400 patients with over 30,000 patches successfully applied to humans in Phase 1 and Phase 2 clinical studies. Learn more at www.zosanopharma.com.
SOURCE: Zosano Pharma
Post Views: 100
