Patients gain power over pain, plus 4 more FDA approvals

May 8, 2015

News

Article

Patients who are recovering from surgery in the hospital now have the opportunity to control their analgesic dosing, plus 4 more new therapies approved by FDA.

Patient-controlled pain drug device approved by FDA

Patients who are recovering from surgery in the hospital now have the opportunity to control their analgesic dosing. Ionsys (fentanyl iontophoretic transdermal system) from The Medicines Company has just been approved by FDA for this use.

The pain drug device is the first needleless, patient-controlled, preprogrammed, opioid-based treatment available for the short-term management of acute postoperative pain in hospitalized adults needing opioid analgesia. Postsurgical patients recovering in the hospital can control their analgesic dosing by pushing a button as needed to deliver fentanyl transdermally via an imperceptible electrical current.

According to Eugene R. Viscusi, MD, professor of anesthesiology and director of acute pain management at Thomas Jefferson University, Philadelphia, the new pain drug device “fits well in a multimodal analgesic approach allowing opioid administration as a complement to other nonopioid based therapies.” Dr Viscusi further explains that “The simplicity of this device may make patient mobility and physical therapy easier while reducing the potential burdens associated with a programmable pump.”

FDA based its approval on 3 placebo-controlled trials establishing the device’s efficacy and safety. Product safety was also further established by another 4 active-controlled randomized trials.

For hospitalized patients to use this pain drug device, they will need to be enrolled in its Risk Evaluation Mitigation Strategy (REMS) program. The REMS serves the purpose of mitigating the risk for respiratory depression that could result from accidental exposure to others in whom it has not been prescribed.

The fentanyl iontophoretic transdermal system is not intended for home use.

The manufacturer anticipates its availability in the United States in the third quarter of 2015. It is already being used in Europe, having been approved there in 2006.

NEXT: Nonsurgical double-chin injectable wins FDA approval

Nonsurgical double-chin treatment wins FDA approval

FDA’s approval of Kybella (deoxycholic acid), a less-invasive, nonsurgical option for adults with moderate-to-severe fat below the chin, known as submental fat, or double chin, bodes well for the future of Kythera Biopharmaceuticals, according to an industry insider.

Santilli“The new product will fill a growing need by a large population of Americans who wish to maintain a youthful appearance and in their own way delay signs of aging,” said John Santilli partner, Access Market Intelligence, in Trumbull, Conn.

“Nonsurgical procedures growth is exploding in the US aesthetics market and this product should be able to grow with the market,” he said.

Related: FDA drug approvals

Kybella is identical to the deoxycholic acid that is produced in the body. Deoxycholic acid produced in the body helps the body absorb fats. Kybella is a cytolytic drug, which when injected into tissue physically destroys the cell membrane. When properly injected into submental fat, the drug destroys fat cells; however, it can also destroy other types of cells, such as skin cells, if it is inadvertently injected into the skin, according to an FDA press release.

Using Kybella for the treatment of fat outside of the submental area is not approved and not recommended. It should not be used if there is an infection at the injection site. Caution should also be used in patients who have had prior surgical or aesthetic treatment of the submental area.

Kybella is administered as an injection into the fat tissue in the submental area. Patients may receive up to 50 injections in a single treatment, with up to 6 single treatments administered no less than 1 month apart. Kybella is being provided in single patient use vials and should not be diluted or mixed with any other compounds.

Two clinical trials which enrolled 1,022 adult participants with moderate or severe submental fat established the safety and effectiveness of Kybella for this indication. Participants were randomly assigned to receive Kybella or a placebo for up to 6 treatments. The results showed that reductions in submental fat were observed more frequently in participants who received Kybella versus placebo.

Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. Swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area were the most common side effects of Kybella.

Kybella is being distributed in a dispensing pack that has a unique hologram on the vial label. If there is no hologram, do not use the product.

NEXT: Breo Ellipta approved for asthma in adults

FDA approves Breo Ellipta for treatment of asthma in adults

FDA has approved fluticasone furoate/vilanterol (Breo Ellipta, Theravance, Inc.) for the treatment of asthma in adults.

Asthma is a chronic lung disease that causes inflammation and narrowing of the airways. It causes recurring periods of wheezing, chest tightness, shortness of breath, and coughing. Approximately 19 million American adults suffer from asthma currently and despite medical advances, many patients continue to experience poor control and significant symptoms.

Breo Ellipta is a fixed-dose combination of fluticasone furoate, which is an inhaled corticosteroid (ICS), and vilanterol, which is a long-acting beta 2 agonist (LABA). The fluticasone reduces inflammation while the vilanterol acts to open the airways. Breo Ellipta is administered using the Ellipta dry powder inhaler and comes in 2 strengths, 100/25 μg and 200/25 μg.

Breo Ellipta was originally approved by FDA in May 2013 for the long-term, once daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). With the new approval, Breo Ellipta is now indicated for the once-daily treatment of asthma in patients aged 18 years and older as well. FDA declined to approve the drug for use in younger asthma patients and told the manufacturer additional data would be required to demonstrate safety and efficacy in a younger population.

Breo Ellipta should only be prescribed for patients who are not adequately controlled on a long-term asthma control medication or whose disease severity warrants combination therapy. The drug should not be used for the relief of acute bronchospasm. The most common side effects seen in the trials that studied Breo Ellipta use in asthma included nasopharyngitis, headache, and oropharyngeal pain.

NEXT: Spray-dried sealant stops bleeding

FDA approves first spray-dry sealant to stop bleeding

FDA approved Raplixa (fibrin sealant [human]), used to help control bleeding during surgery, on April 30.

Manufactured by ProFibrix BV, a wholly owned subsidiary of The Medicines Company in Parsippany, N.J., Raplixa is the first spray-dried fibrin sealant approved by the agency.

Raplixa helps control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. “This results in the formation of blood clots to help stop the bleeding,” according to an FDA statement.

Raplixa contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the risk for the transmission of blood-borne viruses. The fibrin sealant components are then spray-dried, blended and packaged in a vial.

Related:F DA drug approvals

“The spray-drying process used to manufacture Raplixa produces dried powders that can be combined into a single vial. This eliminates the need to combine the fibrinogen and thrombin before use and allows the product to be stored at room temperature,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research.

Raplixa can be applied directly from the original product vial or by spraying with a delivery device onto a bleeding site. It is approved for use in conjunction with an absorbable gelatin sponge.

In support of approval, FDA reviewed data from a clinical study involving 719 participants over 11 months, undergoing different types of surgical procedures. The study demonstrated Raplixa’s effectiveness by comparing the reduction in the time needed for bleeding to stop when using this fibrin sealant and the time needed for bleeding to stop when using an absorbable sponge alone.

The most commonly reported adverse reactions were surgical pain, nausea, constipation, fever and decreased blood pressure.

NEXT: Codeine-based cough-cold medicine fills market need

FDA approves cough, cold drug

FDA has approved codeine polistirex and chlorpheniramine polistirex (Tuzistra XR, Vernalis plc and Tris Pharma) extended-release oral suspension, CIII (DEA Schedule III).

Tuzistra XR is the only codeine-based extended-release oral suspension cough-cold treatment that is dosed every 12 hours, in a US prescription cough cold market which sees 30 to 35 million prescriptions written each year. Short-acting codeine-based treatment options account for approximately 38% of this market.

Tuzistra XR was developed using a liquid sustained-release technology, LiquiXR which enables 12 hour dosing.

Parker

“Until now, physicians looking for an extended-release prescription antitussive that is dosed every 12 hours have been limited to DEA Schedule II products such as hydrocodone combination products,” said Thomas Parker, senior vice president commercial operations, Vernalis. “Tuzistra XR is the only option that gives physicians the same extended-release dosing, but is a Schedule III product.”

Tuzistra XR will be priced competitively with other branded prescription antitussives, according to Parker. Pricing information will be available upon product availability.

Cough is the most common complaint seen by primary care physicians. It accompanies the common cold up to 83% of the time and was reported as a symptom in 47% of patients diagnosed with allergic rhinitis.